FDA.reportPublic FDA data

Johnson and Johnson First Aid All Purpose

Manufacturer
Kenvue Brands LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:42:45

Label at a glance#

ProductJohnson and Johnson First Aid All Purpose 160 CT
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure27 sections

Indications and uses

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Diphenhydramine HCL 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions?

OTC - QUESTIONS SECTION

call toll-free 800-524-2624 (English/Spanish) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each gram)Purpose
Neomycin Sulfate (3.5 mg)First aid antibiotic
Polymyxin B Sulfate (10,000 units)First aid antibiotic
Pramoxine HCl (10 mg)External analgesic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

call 800-223-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Johnson & Johnson ®

ALL-PURPOSE

FIRST AID KIT

NEW

160

PIECES

$27 VALUE WITH

REFILLABLE CASE

Johnsons_160 CTJohnsons_160 CT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSN3
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN3
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN3
209459Tylenol Extra Strength 500 MG Oral TabletPSN3
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD3
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD3
198440acetaminophen 500 MG Oral TabletSCD3
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD3
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD3
198440APAP 500 MG Oral TabletSY3
209459APAP 500 MG Oral Tablet [Tylenol]SY3
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY3
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY3
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY3
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY3
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY3
209459Tylenol 500 MG Oral TabletSY3
209459Tylenol Extra Strength 500 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381372020453GTIN-13: 0381372020453
EAN-13: 0381372020453
GTIN-12: 381372020453
UPC-A: 381372020453
GTIN storage (14 digits): 00381372020453		Johnsons_160 CT.jpg
Data codeData Matrix30050173Johnsons_160 CT.jpg
Data codeData Matrix30050174Johnsons_160 CT.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-449-08Johnson and Johnson First Aid All Purpose160 CT2 in 1 POUCHTABLET, FILM COATED4500 mg3
69968-0055-2Johnson and Johnson First Aid All Purpose160 CT14.2 g in 1 TUBECREAM14.2 g10 mg in 1g3
69968-0055-2Johnson and Johnson First Aid All Purpose160 CT1 in 1 CARTONCREAM10 mg in 1g3
69968-0223-1Johnson and Johnson First Aid All Purpose160 CT1 in 1 CARTONCREAM20 mg in 1g3
69968-0223-1Johnson and Johnson First Aid All Purpose160 CT28.3 g in 1 TUBECREAM28.3 g1 mg in 1g3
69968-0726-9Johnson and Johnson First Aid All Purpose160 CT1 in 1 PACKAGEKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-449-00EA - Each50580-4496d4b05b4-6ad3-4928-8e25-c8b959463b2d12012-07-24
50580-449-05EA - Each50580-44988acde81-d037-4e5c-bb0c-84fb4f0c8a8712012-07-24
50580-449-07EA - Each50580-44920279d46-6713-4547-84fb-9a08de2e2d1512012-07-24
50580-449-09EA - Each50580-449c71a951e-137e-45aa-9cf4-fcf45d883ade12012-07-24
50580-449-10EA - Each50580-4493e2a7f0e-aa78-48c7-ad46-b671d85aa97912012-07-24
50580-449-12EA - Each50580-449241c2584-6250-4617-9d2b-bea53196e24512014-11-05
50580-449-13EA - Each50580-449e9e4683d-f503-45ba-935a-cfc8788a114a12015-10-02
50580-449-15EA - Each50580-44972f946f0-efd3-40f2-a3f4-b5bb480bb2f512012-07-24
50580-449-23EA - Each50580-449eb924eae-392e-408d-99ad-5b9ccf2f4b1e12012-07-24
50580-449-35EA - Each50580-449ccc5e685-e933-4c54-9a29-4f520edd3cf212013-03-03
50580-449-36EA - Each50580-449fe30c11b-8a2f-49f0-b4f9-7e2c03350a3612013-03-03
50580-449-37EA - Each50580-449d5cb5c35-153e-4f83-b28f-be9370e40ddd12026-04-20
50580-449-61EA - Each50580-449690e1cfe-fa00-469e-9039-75db9bb6375b12023-05-05
69968-0223-1GM - Gram69968-02236bb12e4b-56e2-4424-9641-c234236d08c912019-09-05
69968-0055-1GM - Gram69968-00553bd0c333-eec9-4f81-8788-875ee16f75bd12020-04-20

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-072669968-0726-9
50580-44950580-449-08
69968-022369968-0223-1
69968-005569968-0055-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
SULFURIC ACIDO40UQP6WCFIACT
SODIUM HYDROXIDE55X04QC32IIACT
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RINGR
ISOPROPYL ALCOHOLND2M416302INGR
BENZALKONIUM CHLORIDEF5UM2KM3W7INGR
SODIUM BICARBONATE8MDF5V39QOINGR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-15full-release2026-06-01 00:37:38

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
ndc (package): 50580-449-08
ndc (product): 50580-449
ndc11 (package): 50580044908
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
ndc (package): 69968-0223-1
ndc (package): 50580-449-08
ndc (package): 69968-0055-2
ndc11 (package): 50580044908
ndc11 (package): 69968022301
ndc11 (package): 69968005502
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
ndc (package): 50580-449-08
ndc (package): 69968-0055-2
ndc11 (package): 50580044908
ndc11 (package): 69968005502
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
ndc (package): 69968-0223-1
ndc (package): 69968-0726-9
ndc (package): 50580-449-08
ndc (package): 69968-0055-2
ndc (product): 69968-0726
ndc11 (package): 50580044908
ndc11 (package): 69968022301
ndc11 (package): 69968005502
ndc11 (package): 69968072609
spl id: 4248507f-34c4-a703-e063-6294a90a5267
spl set id: f3933330-2550-4a88-e053-2a95a90a3997
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
ndc (package): 69968-0055-2
ndc (product): 69968-0055
ndc11 (package): 69968005502
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
ndc (package): 69968-0223-1
ndc (product): 69968-0223
ndc11 (package): 69968022301

Reported adverse events (FAERS/openFDA)#

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