Storage and handling
Other Information: Store at room temperature
Other Information: Store at room temperature
ACTIVE INGREDIENTS:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
Purpose: First aid antiseptic, external analgesic
Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with:
Minor Cuts
Scrapes
Burns
Warnings:
For external use only
Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week
Keep out of reach of Children.
If ingested, contact a Poison Control Center right away.
Directions: Clean affected area, Apply small amount not more than 3 times daily.
May be covered with a sterile bandage.
Other Information:
Store at room temperature
LOT/EXP: Made in CHINA
20130301
Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
Genuine First Aid.
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%.......... First Aid Antiseptic
Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Warning: For external use only.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Do not use in the eyes or over large areas of the body.
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Inactive Ingredient: Purified water
LOT/EXP: Made in CHINA
20130301
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Active Ingredient: Purpose:
Benzocaine, 6% w/v.................. Topical Anesthetic
SD alcohol, 60% w/v.................. Antiseptic
Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
Warnings: For external use only.
Avoid contact with eyes. If this happens, rinse thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Flammable - keep away from fire or flame.
Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.
Made in CHINA
LOT/EXP:
Insect Sting Relief Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Active ingredient (in each tablet) Purpose
Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Uses temporarily relieves minor aches and pains due to:
the common cold
headache
toothache
muscular aches
backache
minor pain of arthritis
menstrual cramps temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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
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 stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic
Ask a doctor before use if you are:
taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; 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 get better; 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 symptoms appear
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 definitely 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 use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.
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: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets
Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
IBUPROFEN 2 Tablets
Active Ingredient (in each tablet) Purpose
Acetaminophen 325 mg ............. Analgesic/antipyretic
Uses
temporary relief of minor aches and pains associated with:
common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever
Warnings:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product
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 the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of age needed. Do not take more than 5
tablets in 24 hours.
Children under 6 Do not use this regular strength product.
years of age This will provide more than the recommended dose (overdose) and could
cause serious health problems.
Store at 59-86 degree Fahrenheit (15-30 degree Celcius)
tamper evident sealed packets; do not use any open or torn packets
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
GENUINE FIRST AID 2 Tablets
NON-ASPIRIN
Active Ingredient (in each tablet) Purpose
Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer
*nonsteroidal anti-inflammatory drug
Uses Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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: Aspirin may cause a severe allergic reaction which 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 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 thinner (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
Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis
Ask a doctor before use if: 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, or kidney disease; you are taking a diuretic
Ask a doctor or pharmacist before use if you are:
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; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely 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 use more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
do not take longer than 10 days, unless directed by a doctor
Adults and children: (12 years and older) Take 1 or 2 tablets with
water every 4 hours as needed. Do not take more than 12 tablets in 24
hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.
Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid
excessive heat and humidity; tamper evident sealed packets;
Do not use any opened or torn packets
Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch
Distributed by GENUINE FIRST AID
600 Clevelad Str Suite 400, Clearwater, FL 33755
ASPIRIN 2 Tablets
CARRYING CASE
1 Hard Case
1 Easy Access Pocket System
POCKET 1: SMALL CUTS and BURNS
50 Adhesive Plastic Bandages 3/4" X 3"
40 Junior Adhesive Plastic Bandages 3/8" X 1-1/2"
2 Knuckle Fabric Bandages
1 Adhesive Spot Bandages 7/8"X7/8"
1 Fingertip Fabric Bandage
3 Burn Cream
12 Antiseptic Towelettes
10 Cotton Tipped Applicators
POCKET 2: MEDIUM CUTS and SCRATCHES
6 Sterile Gauze Pads 2"X2"
2 Sterile Gauze Pads 3"X3"
1 Roller Gauze Bandage 2" X 4.1yds.
POCKET 3: SEVERE BLEEDING and BURNS
1 First Aid Tape Roll 1/2" X 5yds.
1 Combine Pad 5" X 9"
POCKET 4: CPR
1 CPR Breathing Barrier
POCKET 5: PROTECTION
2 Medical Grade Vinyl Gloves
1 Instant Cold Compress
1 Emergency Blanket 38" X 60"
2 Insect Sting Relief Pads
1 Triangular Bandage 42" X 42" X 59"
4 Ibuprofen 200mg
4 Non Aspirin 325mg
2 Aspirin 325mg
POCKET 6: INSTRUMENTS
1 Emergency First Aid Guide
2 Assorted Safety Pins
-------------------------------------------------------------------------
ESTUCHE PORTATIL
1 Estuche de Plastico
1 Sistema de fundas para rapido acceso
FUNDA 1: CORTADURAS Y QUEMADURAS MENORES
50 Vendas Adhesivas Plasticas 3/4" X 3"
40 Vendas Plasticas Tamano Junior 3/8" X 1-1/2"
2 Vendas de Tela para Nudillos
5 Vendas Adhesivas Redondas 7/8"X7/8"
1 Vendas de tela para yema del dedo
3 Cream para Quemaduras
12 Toallitas Antisepticas
10 Aplicadores con Puntas de Algodon
FUNDA 2: CORTADURAS Y RASGUNOS MEDIANOS
6 Almohadillas Esteril de Gasa 2"X2"
2 Almohadillas Esteril de Gasa 3"X3"
1 Vendas de Gasa en Rollo 2" X 4.1yds.
FUNDA 3: SANGRADO SEVERO Y QUEMADURAS
1 Cinta de papel para Primeros Auxilios 1/2" X 5yds.
1 Almohadilla de Uso Combinado 5" X 9"
FUNDA 4: CPR
1 Mascarilla CPR
FUNDA 5: PROTECCION
2 Guantes de Vinilo
1 Compresa de Frio Instantaneo
1 Manta Termica 38" X 60"
2 Toallitas para Picaduras de Insectos
1 Vendajes Triangulares 42" X 42" X 59"
4 Ibuprofen 200mg
4 Non Aspirin 325mg
2 Aspirin 325mg 325mg
FUNDA 6: INSTRUMENTOS
1 Manual de Primeros Auxilios
2 Imperdibles ( alfileres de gancho )Suite 400
Clearwater, FL 33755
GENUINE FIRST AID.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 12 |
| 212033 | aspirin 325 MG Oral Tablet | PSN | 12 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | 12 |
| 1038561 | benzalkonium Cl 0.4 % Medicated Pad | PSN | 12 |
| 1046313 | benzocaine 6 % / ethanol 60 % Medicated Pad | PSN | 12 |
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | 12 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 12 |
| 212033 | aspirin 325 MG Oral Tablet | SCD | 12 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | 12 |
| 1038561 | benzalkonium chloride 4 MG/ML Medicated Pad | SCD | 12 |
| 1046313 | benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated Pad | SCD | 12 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | 12 |
| 313782 | APAP 325 MG Oral Tablet | SY | 12 |
| 212033 | ASA 325 MG Oral Tablet | SY | 12 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | 12 |
| 1038561 | benzalkonium chloride 0.4 % Medicated Towelette | SY | 12 |
| 1038561 | benzalkonium chloride 0.4 % Topical Swab | SY | 12 |
| 1046313 | benzocaine 6 % / ethanol 60 % Topical Swab | SY | 12 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | 12 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52124-0118-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-06ae-f424-e053-dadaa90a57ce | Auto 157 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52124-0001-1 | Auto 157 | 0.8 mL in 1 PACKAGE | LIQUID | 9.6 mL | 0.40 mL in 100mL | 12 |
| 52124-0004-1 | Auto 157 | 0.9 g in 1 PACKAGE | CREAM | 2.7 g | 0.5 g in 100g | 12 |
| 52124-0008-1 | Auto 157 | 0.5 mL in 1 PACKAGE | LIQUID | 1 mL | 60 mL in 100mL | 12 |
| 52124-0009-1 | Auto 157 | 2 in 1 PACKAGE | TABLET | 4 | 200 mg | 12 |
| 52124-0010-1 | Auto 157 | 2 in 1 PACKAGE | TABLET | 4 | 325 mg | 12 |
| 52124-0011-1 | Auto 157 | 2 in 1 PACKAGE | TABLET | 2 | 325 mg | 12 |
| 52124-0118-1 | Auto 157 | 1 in 1 KIT | KIT | 1 | 12 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52124-0001 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0004 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0008 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0009 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0010 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0011 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| 52124-0118 | AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC] | 12 | Legacy NDC, 7 package rows | 20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 12 | |
| ALCOHOL | ACTIVE INGREDIENT | 3K9958V90M | 12 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 12 | |
| BENZALKONIUM CHLORIDE | ACTIVE INGREDIENT | F5UM2KM3W7 | 12 | |
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 12 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 12 | |
| LIDOCAINE | ACTIVE INGREDIENT | 98PI200987 | 12 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 12 | |
| ALCOHOL | ACTIVE MOIETY | 3K9958V90M | 12 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 12 | |
| BENZALKONIUM | ACTIVE MOIETY | 7N6JUD5X6Y | 12 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 12 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 12 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | 12 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | 12 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 12 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 12 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 12 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 12 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 12 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 12 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 12 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52124-0118 | 52124-0118-1 |
| 52124-0004 | 52124-0004-1 |
| 52124-0001 | 52124-0001-1 |
| 52124-0008 | 52124-0008-1 |
| 52124-0009 | 52124-0009-1 |
| 52124-0010 | 52124-0010-1 |
| 52124-0011 | 52124-0011-1 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / RESPIRATORY (INHALATION) | 44.4 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EFFERVESCENT / ORAL | 96.5 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | CAPSULE / ORAL | 2430 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | PASTE, DENTIFRICE / DENTAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SUSPENSION / ORAL | 7 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 620 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 193.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | DROPS / ORAL | NA | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | POWDER, FOR SUSPENSION / ORAL | 12 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075010-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 91aa1891-7ebd-49e8-b874-e0b550b09bd6 | d0d44c0f-e435-473f-93a4-71a79c6bc04a | 2010-06-07 | Warnings | 91aa1891-7ebd-49e8-b874-e0b550b09bd6 d0d44c0f-e435-473f-93a4-71a79c6bc04a |
Adverse event summaries are temporarily unavailable. Other product information remains available.