DIPHEN- 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

Diphen by

Drug Labeling and Warnings

Diphen by is a Otc medication manufactured, distributed, or labeled by Remedy Pack LLC, Safetec of America, Inc, Allegiant Health, LNK International Inc., Granules India Limited, Ohm Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • USES

    For the relief of the following symptoms associated with

    • acid indigestion
    • sour stomach
    • heartburn
    • upset stomach
  • WARNING

    Do not use

    • 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

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

    Stop use and ask a doctor if

    • symptoms last more than 2 weeks

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

    Keep out of reach of children.

  • DIRECTIONS

    • 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

    • 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

    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*

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

  • USES

    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

    Liver warning

    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

    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

    • 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

    • 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

    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • 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.

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

    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

    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

    • 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

    Active ingredient (in each tablet)

    Meclizine Hydrochloride 25mg

    Purpose

    Antiemetic

  • INACTIVE INGREDIENTS*

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

  • USES

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

    For the reduction of fever.

  • WARNING

    Do not use

    • 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

    • 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

    • 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.

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

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

  • DIRECTIONS

    • 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

    • 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

    Active ingredient (in each tablet)

    Ibuprofen (NSAID2) 200mg


  • 2 nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever/fever reducer

  • INACTIVE INGREDIENTS3

    carnauba wax3, corn starch, hypromellose3, iron oxide red, lactose3, magnesium stearate3, microcrystalline cellulose3, polydextrose3, polyethylene glycol, polyvinyl alcohol3, povidone (K-30)3, silicon dioxide, sodium starch glycolate, stearic acid, talc3, titanium dioxide


  • 3 may contain
  • USES

    Temporarily relieves minor aches and pains associated with

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

    Temporarily reduces fever.

  • WARNING

    Allergy alert

    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

    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

    • 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

    • 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

    • 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

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • 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

    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.

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

  • DIRECTIONS

    • 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

    • 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

    Active ingredient (in each tablet)

    Diphenhydramine HCl 25mg

    Purpose

    Antihistamine

  • INACTIVE INGREDIENTS4

    carnauba wax4, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate4, hypromellose, lactose4, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate4, titanium dioxide


  • 4 may contain
  • USES

    Active ingredients

    Diphenhydramine HCl 25mg

    Purpose

    Antihistamine

    Inactive Ingredients5

    carnauba wax5, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate5, hypromellose, lactose5, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate5, titanium dioxide


  • 5 may contain
  • WARNING

    Do not use

    • 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

    • 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

    • taking sedatives or tranquilizers

    When using this product

    • 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

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

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

  • DIRECTIONS

    • 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

    • 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

    Active ingredient (in each tablet)

    Acetaminophen 500mg

    Purpose

    Pain reliever/fever reducer

  • INACTIVE INGREDIENTS6

    corn starch, hypromellose, maltodextrin6, microcrystalline cellulose6, polyethylene glycol, povidone6, pregelatinized starch6, sodium starch glycolate6, stearic acid, titanium dioxide6


  • 6 may contain
  • USES

    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

    Liver warning

    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

    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

    • 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

    • liver disease

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    Stop using and ask a doctor if

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

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

    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

    • 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

    • 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

    Active ingredient (in each tablet)

    Loratadine 10mg

    Purpose

    Antihistamine

  • INACTIVE INGREDIENTS*

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • USES

    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

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

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

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

    Stop use and ask a doctor if

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

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

    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

    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

    • 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

    Serving Size: 2 tablets

    Servings Per Packet: 1

    OTHER INGREDIENTS

    microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

    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

    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

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

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

  • DIRECTIONS

    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

    • 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

    Active ingredient (in each tablet)

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

    Purpose

    Upset stomach reliever/antidiarrheal

  • INACTIVE INGREDIENTS*

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

  • USES

    Temporarily relieves

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

    Reye's syndrome

    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

    Contains salicylate. Do not take if you are:

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

    Do not use if you have

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

    Ask a doctor before use if you have

    • fever
    • mucus in the stool

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

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

    Stop use and ask a doctor if

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

    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.

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

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

  • DIRECTIONS

    • 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

    • 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

    REMEDY PACK

    DRUG FACTS

    www.theremedypack.com

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    DIPHEN 
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82652-021
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-021-011 in 1 CARTON05/10/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKET 3 g
    Part 22 PACKET 1.8 g
    Part 34 PACKET 3.6 g
    Part 48 PACKET 4 g
    Part 52 PACKET
    Part 64 PACKET
    Part 74 PACKET
    Part 84 PACKET
    Part 94 PACKET
    Part 102 PACKET
    Part 113 PACKET
    Part 124 PACKET
    Part 133 PACKET
    Part 1 of 13
    PAIN RELIEF 
    benzocaine liquid
    Product Information
    Item Code (Source)NDC: 82652-033(NDC:61010-8100)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    polyethylene glycol 400 (UNII: B697894SGQ)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    peppermint oil (UNII: AV092KU4JH)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-033-010.75 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2010
    Part 2 of 13
    BURN 
    benzalkonium chloride and lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC: 82652-029(NDC:47682-940)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 g
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    White Petrolatum (UNII: B6E5W8RQJ4)  
    White Wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-029-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/29/2017
    Part 3 of 13
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC: 82652-027(NDC:47682-923)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    White Wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-027-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/01/2021
    Part 4 of 13
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC: 82652-028(NDC:47682-932)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [USP'U]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    FD&C Red No. 3 (UNII: PN2ZH5LOQY)  
    D&C Red No. 28 (UNII: 767IP0Y5NH)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-028-010.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B06/04/2018
    Part 5 of 13
    ALCALAK 
    calcium carbonate tablet, chewable
    Product Information
    Item Code (Source)NDC: 82652-023(NDC:47682-201)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Calcium Carbonate420 mg
    Inactive Ingredients
    Ingredient NameStrength
    Aspartame (UNII: Z0H242BBR1)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Acacia (UNII: 5C5403N26O)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Sorbitol (UNII: 506T60A25R)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-023-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33106/15/2014
    Part 6 of 13
    I-PRIN 
    ibuprofen tablet, film coated
    Product Information
    Item Code (Source)NDC: 82652-024(NDC:47682-683)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Lactose, Unspecified Form (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polydextrose (UNII: VH2XOU12IE)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)  
    Povidone K30 (UNII: U725QWY32X)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-024-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501002/01/2021
    Part 7 of 13
    LORADAMED 
    loratadine tablet, film coated
    Product Information
    Item Code (Source)NDC: 82652-022(NDC:47682-203)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RX;526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-022-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613412/30/2008
    Part 8 of 13
    COLD RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Item Code (Source)NDC: 82652-032(NDC:47682-725)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-032-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2021
    Part 9 of 13
    DIPHEN 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Item Code (Source)NDC: 82652-031(NDC:47682-166)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    D&C Red No. 27 (UNII: 2LRS185U6K)  
    Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Lactose, Unspecified Form (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-031-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2021
    Part 10 of 13
    MEDI-LYTE 
    calcium carbonate, potassium chloride, and magnesium oxide tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate27 mg
    Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) Potassium Chloride80 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Oxide20 mg
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT05/10/2022
    Part 11 of 13
    MEDI-MECLIZINE 
    meclizine hydrochloride tablet
    Product Information
    Item Code (Source)NDC: 82652-030(NDC:47682-481)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) Meclizine Hydrochloride25 mg
    Inactive Ingredients
    Ingredient NameStrength
    Anhydrous Lactose (UNII: 3SY5LH9PMK)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-030-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33612/14/2020
    Part 12 of 13
    EXTRA STRENGTH APAP 
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source)NDC: 82652-025(NDC:47682-043)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-025-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/01/2021
    Part 13 of 13
    DIOTAME 
    bismuth subsalicylate tablet, chewable
    Product Information
    Item Code (Source)NDC: 82652-026(NDC:47682-210)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) Bismuth Subsalicylate262 mg
    Inactive Ingredients
    Ingredient NameStrength
    Acacia (UNII: 5C5403N26O)  
    Aspartame (UNII: Z0H242BBR1)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    D&C Red No. 27 (UNII: 2LRS185U6K)  
    Dextrates (UNII: G263MI44RU)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code RH;046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 82652-026-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33504/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613405/10/2022
    Labeler - Remedy Pack LLC (101454060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(82652-021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Remedy Pack LLC101454060RELABEL(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026) , REPACK(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930MANUFACTURE(82652-021)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International Inc.966812120MANUFACTURE(82652-021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236MANUFACTURE(82652-021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories051565745MANUFACTURE(82652-021)

  • Trademark Results [Diphen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIPHEN
    DIPHEN
    88391253 not registered Live/Pending
    2R Investments, LLC
    2019-04-18
    DIPHEN
    DIPHEN
    81021808 1021808 Dead/Cancelled
    Pilot Chemical Company
    0000-00-00
    DIPHEN
    DIPHEN
    73604180 1520475 Dead/Cancelled
    MY-K LABORATORIES, INC.
    1986-06-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.