Genuine First Aid - Home First Aid

Manufacturer
Genuine First Aid, LLC
Effective date
2011-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:26:56

Label at a glance#

ProductGenuine First Aid - Home First Aid
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, IBUPROFEN, ACETAMINOPHEN, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL
Label structure66 sections

Storage and handling

Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                                        Purpose

Isopropyl Alcohol, 70% v/v...............        Antiseptic

OTC - PURPOSE SECTION

Use:    For preparation of skin before injection.

WARNINGS SECTION

Warnings:    For external use only.

STORAGE AND HANDLING SECTION

Flammable - keep away from fire or flame

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

OTC - DO NOT USE SECTION

Do not use: with electrocautery, in the eyes.

OTC - STOP USE SECTION

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

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.

OTC - WHEN USING SECTION

Wipe Injection site vigorously and discard.

INACTIVE INGREDIENT SECTION

Inactive Ingredient:    Purified water.

DESCRIPTION SECTION

LOT/EXP:                Made in CHINA

20140301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: .........Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

OTC - PURPOSE SECTION

Uses:  To help prevent infection in:
minor cuts;  scrapes;  burns

WARNINGS SECTION

Warnings:

For external use only.

OTC - DO NOT USE SECTION

Do not use:  in eyes;  over large areas of the body;

If allergic to any of the ingredients;  for more than one week unless directed by a physician.

OTC - STOP USE SECTION

Stop use and consult a doctor:

if 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 ingested, contact a Poison

Control Center right away.

OTC - WHEN USING SECTION

Directions: clean affected area;  apply 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

STORAGE AND HANDLING SECTION

Other information:

Store at room temperature.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

 Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                       Purpose

Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION


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 SECTION



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

OTC - DO NOT USE SECTION


Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION

When using this product:
take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

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

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 definitely 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.

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION


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 INGREDIENT SECTION

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.

DESCRIPTION SECTION

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN 2 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN   2 Tablets

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)                      Purpose

Acetaminophen 500 mg...............................   Pain Reliever / fever reducer

OTC - PURPOSE SECTION

Purpose: Pain reliever, fever reducer

INDICATIONS & USAGE SECTION

Uses   for the temporary relief of minor aches and pains associated with
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

WARNINGS SECTION

Warnings

Liver Warning: This product contains acetaminophen. Sever 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.

OTC - DO NOT USE SECTION

Do not use:  with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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 swellign is present

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 to children under 12 years of age.

STORAGE AND HANDLING SECTION

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                                 Purpose

Benzalkonium Chloride 0.40%..........   First Aid Antiseptic

OTC - PURPOSE SECTION

Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

WARNINGS SECTION

Warning:   For external use only.

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.

OTC - STOP USE SECTION

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

OTC - DO NOT USE SECTION

Do not use in the eyes or over large areas of the body.

OTC - WHEN USING SECTION

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

INACTIVE INGREDIENT SECTION

Inactive Ingredient:   Purified water

DESCRIPTION SECTION

LOT/EXP:                           Made in CHINA

20130301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AntisepticTowelette
AntisepticTowelette

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GenuineTripleAntibioticGenuineTripleAntibiotic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen 200mgIbuprofen 200mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AlcoholCleansingPadAlcoholCleansingPad

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP_PDP
APAP_PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

apap_pdp
apap_pdp

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOME KIT FRONT
HOME KIT FRONT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOME KIT BACK
HOME KIT BACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN2
1038561benzalkonium Cl 0.4 % Medicated PadPSN2
310965ibuprofen 200 MG Oral TabletPSN2
797544isopropyl alcohol 70 % Medicated PadPSN2
198440acetaminophen 500 MG Oral TabletSCD2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
1038561benzalkonium chloride 4 MG/ML Medicated PadSCD2
310965ibuprofen 200 MG Oral TabletSCD2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
198440APAP 500 MG Oral TabletSY2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2
1038561benzalkonium chloride 0.4 % Medicated ToweletteSY2
1038561benzalkonium chloride 0.4 % Topical SwabSY2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2
797544isopropyl alcohol 70 % Medicated PadSY2
797544isopropyl alcohol 70 % Topical ClothSY2
797544isopropyl alcohol 70 % Topical SwabSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
NEOMYCIN 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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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52124-1200-12019-10-29C16284748780-1960f7f55-d35b-8e05-e053-dbdaa90a074aGenuine First Aid Home First Aid Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-175-46Genuine First Aid - Home First Aid2 in 1 PACKETTABLET, FILM COATED2500 mg2
52124-0001-1Genuine First Aid - Home First Aid0.8 mL in 1 PACKAGESWAB1.6 mL0.40 mL in 100mL2
52124-0002-1Genuine First Aid - Home First Aid0.5 mL in 1 PACKAGELIQUID1 mL70 mL in 100mL2
52124-0003-1Genuine First Aid - Home First Aid.5 g in 1 TUBEOINTMENT0.5 g5000 [iU] in 1g2
52124-0009-1Genuine First Aid - Home First Aid2 in 1 PACKETTABLET2200 mg2
52124-1200-1Genuine First Aid - Home First Aid1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-175GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Current NDC, Legacy NDC20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip
52124-0001GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Legacy NDC20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip
52124-0002GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Legacy NDC20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip
52124-0003GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Legacy NDC20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip
52124-0009GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Legacy NDC20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip
52124-1200GENUINE FIRST AID - HOME FIRST AID (BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN) KIT [GENUINE FIRST AID, LLC]2Legacy NDC, 6 package rows20110118_56269be0-68c6-41da-a43d-da4db593db0a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-175-13EA - Each47682-175c9f82a9e-9417-4f93-bb3a-27e3962ea6e812012-07-24
47682-175-33EA - Each47682-1757d5d8be4-afc5-487c-9350-face2a62666c12012-07-24
47682-175-48EA - Each47682-175321de510-dc8a-4f76-b96e-665741a7c5ef12012-07-24
47682-175-64EA - Each47682-1756a68a6a0-350a-4c84-8a44-4a08bbf3a81312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES2
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W72
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266932
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D42
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
BACITRACINACTIVE MOIETY58H6RWO52I2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022
NEOMYCINACTIVE MOIETYI16QD7X2972
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSPOVIDONEINACTIVE INGREDIENT68401960MK2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A2
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TRIACETININACTIVE INGREDIENTXHX3C3X6732
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TRIACETINTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED / ORAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, FILM COATED / ORAL392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED / ORAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET, FILM COATED / ORAL392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 · 1 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…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDIQUE APAP Extra StrengthACETAMINOPHENUnifirst First Aid Corporation56822785-d5fb-4869-971e-5de637c2eda82025-09-08WarningsExact identifier
ndc (product): 47682-175
aca196dc-cdfb-4702-a04d-72a81b70d4d756269be0-68c6-41da-a43d-da4db593db0a2011-01-17WarningsExact identifier
spl id: aca196dc-cdfb-4702-a04d-72a81b70d4d7
spl set id: 56269be0-68c6-41da-a43d-da4db593db0a

Reported adverse events (FAERS/openFDA)#

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