FDA.reportPublic FDA data

Diphen

Manufacturer
Remedy Pack LLC | Safetec of America, Inc | Allegiant Health | LNK International Inc. | Granules India Limited | Ohm Laboratories
Effective date
2022-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:11

Label at a glance#

ProductDiphen
Active ingredientbenzocaine, Benzalkonium Chloride, Lidocaine Hydrochloride, HYDROCORTISONE ACETATE, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, Bismuth Subsalicylate
Label structure92 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes and burns. For the temporary relief of pain and itching associated with: sunburn insect bites cuts minor skin irritations scrapes minor burns

Dosage and administration

Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage Children under 12 years: consult a doctor Children under 2 years: consult a doctor

Storage and handling

store in a cool, dry area 59° to 79°F (15° to 25°C) tamper evident sealed packets do not use any opened or torn packets

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

REMEDY PACK

SPL UNCLASSIFIED SECTION

Burn Cream

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

Topical antiseptic, Topicall analgesic

USES

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

  • sunburn
  • insect bites
  • cuts
  • minor skin irritations
  • scrapes
  • minor burns

WARNING

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

OTC - STOP USE SECTION

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage
  • Children under 12 years: consult a doctor
  • Children under 2 years: consult a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store in a cool, dry area 59° to 79°F (15° to 25°C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

SPL UNCLASSIFIED SECTION

Triple Antibiotic

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Purposes

OTC - PURPOSE SECTION

First aid antibiotics

USES

INDICATIONS & USAGE SECTION

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

WARNING

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor

Ask a doctor before use

OTC - ASK DOCTOR SECTION

in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

the condition persists or gets worse a rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
may be covered with a sterile bandage

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 15°C to 30°C (59°F to 86°F) (do not freeze) tamper evident. Do not use if packet is torn, cut or opened.
  • avoid excessive heat and humidity

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

mineral oil, white petrolatum

SPL UNCLASSIFIED SECTION

Hydrocortisone Cream

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

USES

INDICATIONS & USAGE SECTION

  • eczema
  • insect bites
  • poison ivy
  • Poison oak
  • poison sumac
  • Cosmetics
  • jewelry
  • soaps detergents
  • seborrheic
  • dermatitis
  • Psoriasas

Other uses of this product should only be under the advice and supervision of a doctor.

WARNING

WARNINGS SECTION

  • For external use only
  • avoid contact with the eyes
  • if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor

OTC - DO NOT USE SECTION

  • do not use for the treatment of diaper rash.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • If swallowed, get medical help or consult a poison control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adult and children (2 years and over): apply to affected not more than 3 to 4 times daily

Children under 2 years: Consult a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 59-86ºF (15-30ºC)
  • do not freeze
  • do not use any opened or torn packets.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white Wax.

SPL UNCLASSIFIED SECTION

Oral Pain Relief Gel

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

USES

INDICATIONS & USAGE SECTION

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

WARNINGS SECTION

METHEMOGLOBINEMIA WARNING

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

ALLERGY ALERT

SPL UNCLASSIFIED SECTION

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.

Do not use

OTC - DO NOT USE SECTION

For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If it occurs, flush with water.

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

  • If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding,ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 15°C to 30°C (59°F to 86°F)
  • protect from freezing

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Flavoring, PEG 3350, PEG 400, sodium sacchrin, water.

May contain blue #1, green #3, green #5 , red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as color additive.

SPL UNCLASSIFIED SECTION

Alcalak

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 420mg

Purpose

OTC - PURPOSE SECTION

Antacid

INACTIVE INGREDIENTSmay contain

INACTIVE INGREDIENT SECTION

aspartame, croscarmellose sodium, gum acacia, magnesium stearate, maltodextrin, mineral oil, mint flavor, sorbitol, sucrose

USES

INDICATIONS & USAGE SECTION

For the relief of the following symptoms associated with

  • acid indigestion
  • sour stomach
  • heartburn
  • upset stomach

WARNING

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 2 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains phenylalanine 1.5mg per tablet
  • each tablet contains 168mg of elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC) in a dry place
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Cold Relief

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION
Active ingredient (in each tablet): Acetaminophen 325mgPurpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mgPurpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mgPurpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mgPurpose: Nasal decongestant

INACTIVE INGREDIENTS*

INACTIVE INGREDIENT SECTION

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

USES

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

WARNING

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of the ingredients.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • you get nervous, dizzy or sleepless
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Medi-Meclizine

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine Hydrochloride 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

INACTIVE INGREDIENTS*

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

USES

INDICATIONS & USAGE SECTION

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

For the reduction of fever.

WARNING

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland if you are
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 59- 86º F (15-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

I-Prin

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen (NSAID1) 200mg

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INACTIVE INGREDIENTSmay contain

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, hypromellose, iron oxide red, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone (K-30), silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains associated with

  • headache
  • toothache
  • backache
  • menstrual cramps
  • common cold
  • muscular aches
  • minor arthritis pain

Temporarily reduces fever.

WARNING

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • shock

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new or unexpected symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • read all product information before using
  • store at 68-77°F (20-25°C)
  • avoid excessive heat 104°F (above 40°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Diphen

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

INACTIVE INGREDIENTSmay contain

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide

USES

INDICATIONS & USAGE SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Inactive Ingredientsmay contain

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide

WARNING

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each caplet may contain: calcium 25mg
  • protect from light
  • use by expiration date on packet
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Extra Strength APAP

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INACTIVE INGREDIENTSmay contain

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

USES

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

For the reduction of fever.

WARNING

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Loradamed

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

INACTIVE INGREDIENTS*

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

USES

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

WARNING

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children: (12 years and older) Take 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease: Ask a doctor before using.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 68º-77ºF (20º-25ºC)
  • protect from excessive moisture
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Medi-Lyte

Drug Facts

INFORMATION

SPL UNCLASSIFIED SECTION

Serving Size: 2 tablets

Servings Per Packet: 1

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

OTC - ACTIVE INGREDIENT SECTION

Amount Per Serving% Daily Value
Calcium (from 27.0 mg calcium carbonate) 10.8 mg1.06%
Potassium (from 80 mg potassium chloride) 40mg1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg3.0%
Carbohydrates 6 mg>1%
Calories 1.5>1%
Protein0%
Fat0%

USES

INDICATIONS & USAGE SECTION

Nutritional support for the following symptoms due to excessive loss of perspiration

  • heat fatigue
  • muscle cramps
  • heat exhaustion
  • heat stroke
  • replaces lost electrolytes
  • helps provide rapid rehydration

*This statement has not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNING

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children: (12 years and older)

  • take 2 tablets as needed with a full glass of water
  • may be repeated every hour as needed
  • do not exceed 20 tablets in 24 hours

Children under 12 years:

  • Do not give to children under 12 years of age

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 59º-86º F (15º-30º C)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets
  • no sodium added

SPL UNCLASSIFIED SECTION

Diotame

Drug Facts

INGREDIENTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

INACTIVE INGREDIENTS*

INACTIVE INGREDIENT SECTION

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

USES

INDICATIONS & USAGE SECTION

Temporarily relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

WARNING

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

OTC - DO NOT USE SECTION

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist if you are taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

OTC - WHEN USING SECTION

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • chew or crush tablets completely before swallowing
  • do not swallow tablets whole
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours

Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed.

Children under 12 years: Do not give to children under 12 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg of elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REMEDY PACK

DRUG FACTS

www.theremedypack.com

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletPSN1
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN1
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1
308761bismuth subsalicylate 262 MG Chewable TabletPSN1
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1043690hydrocortisone acetate 1 % Topical CreamPSN1
310965ibuprofen 200 MG Oral TabletPSN1
311372loratadine 10 MG 24HR Oral TabletPSN1
995666meclizine HCl 25 MG Oral TabletPSN1
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
198440acetaminophen 500 MG Oral TabletSCD1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1
308761bismuth subsalicylate 262 MG Chewable TabletSCD1
313884calcium carbonate 420 MG Chewable TabletSCD1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
310965ibuprofen 200 MG Oral TabletSCD1
311372loratadine 10 MG Oral TabletSCD1
995666meclizine hydrochloride 25 MG Oral TabletSCD1
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1
198440APAP 500 MG Oral TabletSY1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY1
1043690hydrocortisone acetate 1 % Topical CreamSY1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1
311372loratadine 10 MG 24 HR Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
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56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
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aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82652-021-012025-01-30C16284748780-12cef2736-8a1c-d83d-e063-dadaa90ab31fDiphen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82652-021-01Diphen1 in 1 CARTONKIT11
82652-022-01Diphen1 in 1 PACKETTABLET, FILM COATED410 mg1
82652-023-01Diphen2 in 1 PACKETTABLET, CHEWABLE4420 mg1
82652-024-01Diphen2 in 1 PACKETTABLET, FILM COATED8200 mg1
82652-025-01Diphen2 in 1 PACKETTABLET, FILM COATED8500 mg1
82652-026-01Diphen2 in 1 PACKETTABLET, CHEWABLE6262 mg1
82652-027-01Diphen0.9 g in 1 PACKETCREAM3.6 g10 mg in 1g1
82652-029-01Diphen0.9 g in 1 PACKETCREAM1.8 g1.3 mg in 1g1
82652-030-01Diphen2 in 1 PACKETTABLET625 mg1
82652-031-01Diphen1 in 1 PACKETTABLET, FILM COATED425 mg1
82652-032-01Diphen2 in 1 PACKETTABLET85 mg1
82652-033-01Diphen0.75 g in 1 PACKETLIQUID3 g200 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82652-021DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Legacy NDC, 12 package rows20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-022DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-023DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-024DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-025DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-026DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-027DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-028DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-029DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-030DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-031DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-032DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip
82652-033DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-203-12EA - Each47682-2035c75ae27-7ce9-4d53-a9bc-1b7d1b3fd62b12017-04-05
47682-203-50EA - Each47682-20320e3c3a0-a4c5-4e78-84ad-01463719a1ec12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 105 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82652-02182652-021-01
82652-03382652-033-01
82652-02982652-029-01
82652-02782652-027-01
82652-02882652-028-01
82652-02382652-023-01
82652-02482652-024-01
82652-02282652-022-01
82652-03282652-032-01
82652-03182652-031-01
82652-03082652-030-01
82652-02582652-025-01
82652-02682652-026-01
61010-8100
47682-940
47682-923
47682-932
47682-201
47682-683
47682-203
47682-725
47682-166
47682-481
47682-043
47682-210

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 124 matching rows.

Name, UNII, Kind table
NameUNIIKind
benzocaineU3RSY48JW5ACTIB
polyethylene glycol 400B697894SGQIACT
polyethylene glycol 3350G2M7P15E5PIACT
peppermint oilAV092KU4JHIACT
saccharin sodiumSB8ZUX40TYIACT
sorbic acidX045WJ989BIACT
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Lidocaine HydrochlorideV13007Z41AACTIR
Alcohol3K9958V90MIACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
PropylparabenZ8IX2SC1OHIACT
Water059QF0KO0RIACT
White PetrolatumB6E5W8RQJ4IACT
White Wax7G1J5DA97FIACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB
Alcohol3K9958V90MIACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
PropylparabenZ8IX2SC1OHIACT
Water059QF0KO0RIACT
White Wax7G1J5DA97FIACT
Bacitracin Zinc89Y4M234ESACTIM
Neomycin Sulfate057Y626693ACTIM
Polymyxin B Sulfate19371312D4ACTIM
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
FD&C Blue No. 1H3R47K3TBDIACT
FD&C Green No. 33P3ONR6O1SIACT
D&C Green No. 58J6RDU8L9XIACT
FD&C Red No. 3PN2ZH5LOQYIACT
D&C Red No. 28767IP0Y5NHIACT
FD&C Red No. 40WZB9127XOAIACT
FD&C Yellow No. 5I753WB2F1MIACT
FD&C Yellow No. 6H77VEI93A8IACT
Calcium CarbonateH0G9379FGKACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 2 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075010-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporation32092beb-c177-4b6b-afa4-b4b5d64621f42025-11-21WarningsExact identifier
ndc (product): 47682-203
Medique Medi-MeclizineMECLIZINE HCLUnifirst First Aid Corporationb3fec2df-c41d-0b56-e053-2995a90a35e82025-09-09WarningsExact identifier
ndc (product): 47682-481
Medique at Home IprinIBUPROFENUnifirst First Aid Corporationb5547f33-2a81-867d-e053-2995a90aa2d02025-09-09WarningsExact identifier
ndc (product): 47682-683
Medi-First Plus Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation57ea7f8a-26e2-367e-e053-2a91aa0a93e12025-09-09WarningsExact identifier
ndc (product): 47682-940
Medique AlcalakCALCIUM CARBONATEUnifirst First Aid Corporation60703e3d-52b1-49c4-b4e2-59d96fa09a782025-09-08WarningsExact identifier
ndc (product): 47682-201
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
ndc (product): 47682-210
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
ndc (product): 47682-166
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
ndc (product): 47682-043
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
ndc (product): 61010-8100
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
ndc (product): 47682-923
7e3354b4-6202-423f-bb85-88c0ac01958d5d185f23-8af6-4e36-b514-5662986520a52022-07-11WarningsExact identifier
spl id: 7e3354b4-6202-423f-bb85-88c0ac01958d
spl set id: 5d185f23-8af6-4e36-b514-5662986520a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.