Auto 157

Manufacturer
Genuine First Aid LLC | GFA Production ( Xiamen) Co., Ltd
Effective date
2010-06-07
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 22:24:47

Label at a glance#

ProductAuto 157
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN
Label structure80 sections

Storage and handling

Other Information: Store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

OTC - PURPOSE SECTION

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 SECTION

Warnings:

For external  use only

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children.

If ingested, contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Clean affected area, Apply small amount not more than 3 times daily.

May be covered with a sterile bandage.

STORAGE AND HANDLING SECTION

Other Information:

Store at room temperature

DESCRIPTION SECTION

LOT/EXP:                                    Made in CHINA

20130301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BurnCreamBurnCream

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

AntisepticToweletteAntisepticTowelette

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                                    Purpose:

Benzocaine, 6% w/v..................    Topical Anesthetic

SD alcohol, 60% w/v..................    Antiseptic

OTC - PURPOSE SECTION

Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

WARNINGS SECTION

Warnings: For external use only.

Avoid contact with eyes.  If this happens, rinse thoroughly with water.

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.

STORAGE AND HANDLING SECTION

Flammable - keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

DESCRIPTION SECTION

Made in CHINA

LOT/EXP:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Insect Sting Relief Pad

Genuine First Aid LLC, Clearwater FL 33755
                        www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Insect Sting Relief PadInsect Sting Relief Pad

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

IbuprofenIbuprofen

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)                Purpose

Acetaminophen 325 mg .............        Analgesic/antipyretic

OTC - PURPOSE SECTION

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 SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  In case of accidental overdose, 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

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

Store at 59-86 degree Fahrenheit (15-30 degree Celcius)

GENERAL PRECAUTIONS SECTION

tamper evident sealed packets; do not use any open or torn packets

DESCRIPTION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENUINE FIRST AID            2 Tablets

NON-ASPIRIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non AspirinNon Aspirin

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)                             Purpose

Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer

*nonsteroidal anti-inflammatory drug  

OTC - PURPOSE SECTION

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 SECTION

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

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; if you are taking a prescription drug for gout, diabetes or arthritis

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 high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

under a doctor's care for any serious condition;  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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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.

OTC - WHEN USING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

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 INGREDIENT SECTION

Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

DESCRIPTION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASPIRIN 2 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 325 mgAspirin 325 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 )

Genuine First Aid LLC

814471010167

Copyright c 2010 Genuine First Aid LLC.

All rights reserved.

Manufactured in China for:

Genuine First Aid LLC.

600 Cleveland Street

Suite 400

Clearwater, FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Auto Kit157 LabelAuto Kit157 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN12
212033aspirin 325 MG Oral TabletPSN12
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN12
1038561benzalkonium Cl 0.4 % Medicated PadPSN12
1046313benzocaine 6 % / ethanol 60 % Medicated PadPSN12
310965ibuprofen 200 MG Oral TabletPSN12
313782acetaminophen 325 MG Oral TabletSCD12
212033aspirin 325 MG Oral TabletSCD12
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD12
1038561benzalkonium chloride 4 MG/ML Medicated PadSCD12
1046313benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated PadSCD12
310965ibuprofen 200 MG Oral TabletSCD12
313782APAP 325 MG Oral TabletSY12
212033ASA 325 MG Oral TabletSY12
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY12
1038561benzalkonium chloride 0.4 % Medicated ToweletteSY12
1038561benzalkonium chloride 0.4 % Topical SwabSY12
1046313benzocaine 6 % / ethanol 60 % Topical SwabSY12
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52124-0118-12020-01-31C16284748780-19d75b9d1-06ae-f424-e053-dadaa90a57ceAuto 157

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52124-0001-1Auto 1570.8 mL in 1 PACKAGELIQUID9.6 mL0.40 mL in 100mL12
52124-0004-1Auto 1570.9 g in 1 PACKAGECREAM2.7 g0.5 g in 100g12
52124-0008-1Auto 1570.5 mL in 1 PACKAGELIQUID1 mL60 mL in 100mL12
52124-0009-1Auto 1572 in 1 PACKAGETABLET4200 mg12
52124-0010-1Auto 1572 in 1 PACKAGETABLET4325 mg12
52124-0011-1Auto 1572 in 1 PACKAGETABLET2325 mg12
52124-0118-1Auto 1571 in 1 KITKIT112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52124-0001AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0004AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0008AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0009AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0010AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0011AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip
52124-0118AUTO 157 (BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN) KIT [GENUINE FIRST AID LLC]12Legacy NDC, 7 package rows20100610_d0d44c0f-e435-473f-93a4-71a79c6bc04a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D12
ALCOHOLACTIVE INGREDIENT3K9958V90M12
ASPIRINACTIVE INGREDIENTR16CO5Y76E12
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W712
BENZOCAINEACTIVE INGREDIENTU3RSY48JW512
IBUPROFENACTIVE INGREDIENTWK2XYI10QM12
LIDOCAINEACTIVE INGREDIENT98PI20098712
ACETAMINOPHENACTIVE MOIETY362O9ITL9D12
ALCOHOLACTIVE MOIETY3K9958V90M12
ASPIRINACTIVE MOIETYR16CO5Y76E12
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y12
BENZOCAINEACTIVE MOIETYU3RSY48JW512
IBUPROFENACTIVE MOIETYWK2XYI10QM12
LIDOCAINEACTIVE MOIETY98PI20098712
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO12
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3012
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE12
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A12
POVIDONEINACTIVE INGREDIENTFZ989GH94E12
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU412
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP12
TRIACETININACTIVE INGREDIENTXHX3C3X67312
WATERINACTIVE INGREDIENT059QF0KO0R12

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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 6 · 302 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MCAPSULE / ORAL2430 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673SUSPENSION / ORAL7 mgExact identifier — unii candidate
14 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii candidate
16 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MDROPS / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673POWDER, FOR SUSPENSION / ORAL12 mgExact identifier — unii candidate
14 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii candidate
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
91aa1891-7ebd-49e8-b874-e0b550b09bd6d0d44c0f-e435-473f-93a4-71a79c6bc04a2010-06-07WarningsExact identifier
spl id: 91aa1891-7ebd-49e8-b874-e0b550b09bd6
spl set id: d0d44c0f-e435-473f-93a4-71a79c6bc04a

Reported adverse events (FAERS/openFDA)#

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