FDA.reportPublic FDA data

Johnson and Johnson First Aid All Purpose

Product NDC
69968-0726
11-digit product format
699680726
Labeler code
69968
Product ID
69968-0726_4248507f-34c4-a703-e063-6294a90a5267
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Johnson and Johnson First Aid All Purpose
Brand name suffix
160 CT
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup
1087026Internal RxNorm lookup
1111764Internal RxNorm lookup
1359360Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3933330-2550-4a88-e053-2a95a90a3997Available on FDA.report

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0726JOHNSON AND JOHNSON FIRST AID ALL PURPOSE 160 CT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, 6 package rows20241116_f3933330-2550-4a88-e053-2a95a90a3997.zip

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 142 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tact Cool JellyDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOLSato Pharmaceutical Co., Ltd.f34872c9-91b9-49db-8e41-5b54a069284a2023-12-01WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.348fde05-2797-4410-a1b2-99e64187c4fe2023-12-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP66681906-c5f5-4c57-bb43-9c83cccc00622023-12-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLProficient Rx LPc0df4b8b-2679-4652-9144-a8db916a186b2023-12-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
application number: M017
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsExact identifier
application number: M017
Thera Plus Cool and Heat Pain Relieving Gel MentholMENTHOLFourstar Group USA, Inc.0a225714-ccb1-4676-e063-6294a90aeeb22023-11-30WarningsExact identifier
application number: M017
Bloop Itch Soothing TopicalHYDROCORTISONEThree Nations Corp0b64677e-d4bf-0929-e063-6294a90af1372023-11-30WarningsExact identifier
application number: M017
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
application number: M017
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
application number: M017
IceQuake Analgestic WhiteMETHYL SALICYLATE, MENTHOLSouthern Sales & Service, Inc.54e5dcd5-9987-488d-a758-d0e76d1551822023-11-29WarningsExact identifier
application number: M017
Icequake Coldn Hot medicated patchMENTHOLSouthern Sales & Service, Inc.89202c52-9eb7-4e5a-a709-4a66ab0d3a722023-11-29WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDESouthern Sales & Service, Inc.9089cb78-e9f8-4437-a767-df809a114c4b2023-11-29WarningsExact identifier
application number: M017
Ice Quake Muscle Rub BlueMENTHOLSouthern Sales & Service, Inc.5180f6a3-58f1-4c50-a33b-7d85a3c1b99b2023-11-29WarningsExact identifier
application number: M017
Discount Drug Mart Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEDiscount Drug Mart8579df23-ac07-9df8-e053-2991aa0a8bbb2023-11-29WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf2023-11-28WarningsExact identifier
application number: M017
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf3933330-2550-4a88-e053-2a95a90a39973
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBDf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletSCDf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
198440APAP 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
209459APAP 500 MG Oral Tablet [Tylenol]SYf3933330-2550-4a88-e053-2a95a90a39973
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-449-08505800449082 in 1 POUCHHistorical
69968-0055-26996800550214.2 g in 1 TUBE14.2 gHistorical
69968-0223-1699680223011 in 1 CARTONHistorical
69968-0726-9699680726091 KIT in 1 PACKAGE (69968-0726-9) * 1 CLOTH in 1 PACKET * 2 TABLET, FILM COATED in 1 POUCH (50580-449-08) * 1 TUBE in 1 CARTON (69968-0223-1) / 28.3 g in 1 TUBE * 1 TUBE in 1 CARTON (69968-0055-2) / 14.2 g in 1 TUBE1 kit2022-01-31NoNoCurrent