FDA.reportPublic FDA data

Desitin Maximum Strength Diaper Rash

Product NDC
69968-0061
11-digit product format
699680061
Labeler code
69968
Product ID
69968-0061_26dd439f-d784-6c9b-e063-6394a90a3eff
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-16
Substance
ZINC OXIDE
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-7ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0061-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-7367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0061-1367a005e9d99…383a685ebd0f…

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
Desitin Maximum Strength Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094560Internal RxNorm lookup
1797059Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af64fc2f-c027-4a68-b368-ee06744a2452Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69968-0061-12024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-22024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-32024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-42024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-52024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-72024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-92024-11-25Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-12024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-22024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-32024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-42024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-52024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-72024-07-30Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-92024-07-30Desitin ® Maximum Strength Diaper Rash Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0061-1Desitin Maximum Strength Diaper Rash1 in 1 CARTONPASTE18
69968-0061-1Desitin Maximum Strength Diaper Rash28 g in 1 TUBEPASTE288
69968-0061-2Desitin Maximum Strength Diaper Rash57 g in 1 TUBEPASTE578
69968-0061-2Desitin Maximum Strength Diaper Rash1 in 1 CARTONPASTE18
69968-0061-3Desitin Maximum Strength Diaper Rash136 g in 1 TUBEPASTE1368
69968-0061-3Desitin Maximum Strength Diaper Rash3 in 1 CARTONPASTE38
69968-0061-4Desitin Maximum Strength Diaper Rash113 g in 1 TUBEPASTE1138
69968-0061-4Desitin Maximum Strength Diaper Rash1 in 1 CARTONPASTE18
69968-0061-5Desitin Maximum Strength Diaper Rash1 in 1 CARTONPASTE18
69968-0061-5Desitin Maximum Strength Diaper Rash136 g in 1 TUBEPASTE1368
69968-0061-7Desitin Maximum Strength Diaper Rash3.5 g in 1 POUCHPASTE3.58
69968-0061-9Desitin Maximum Strength Diaper Rash454 g in 1 JARPASTE4548
69968-0061-1Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g4
69968-0061-1Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g4
69968-0061-1Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g3
69968-0061-1Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0061-1GM - Gram69968-0061f10dbdb2-0d9b-41ce-b70a-58f111649b9f12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0061DESITIN MAXIMUM STRENGTH DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 12 package rows20241127_af64fc2f-c027-4a68-b368-ee06744a2452.zip
69968-0061JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]4Current NDC, Legacy NDC20241115_afa1ba48-b504-4af0-a9c7-cd2c9a2e6e59.zip
69968-0061JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC, Legacy NDC20241127_ed08b690-f907-6d2f-e053-2a95a90af51c.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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797059Desitin 40 % Topical PastePSNaf64fc2f-c027-4a68-b368-ee06744a24528
1094560zinc oxide 40 % Topical PastePSNaf64fc2f-c027-4a68-b368-ee06744a24528
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBDaf64fc2f-c027-4a68-b368-ee06744a24528
1094560zinc oxide 0.4 MG/MG PasteSCDaf64fc2f-c027-4a68-b368-ee06744a24528
1797059Desitin 40 % Topical PasteSYaf64fc2f-c027-4a68-b368-ee06744a24528
1094560zinc oxide 40 % PasteSYaf64fc2f-c027-4a68-b368-ee06744a24528
1094560ZNO 0.4 MG/MG PasteSYaf64fc2f-c027-4a68-b368-ee06744a24528
1797059ZNO 0.4 MG/MG Paste [Desitin]SYaf64fc2f-c027-4a68-b368-ee06744a24528
1797059Desitin 40 % Topical PastePSNed08b690-f907-6d2f-e053-2a95a90af51c3
1094560zinc oxide 40 % Topical PastePSNed08b690-f907-6d2f-e053-2a95a90af51c3
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBDed08b690-f907-6d2f-e053-2a95a90af51c3
1094560zinc oxide 0.4 MG/MG PasteSCDed08b690-f907-6d2f-e053-2a95a90af51c3
1797059Desitin 40 % Topical PasteSYed08b690-f907-6d2f-e053-2a95a90af51c3
1094560zinc oxide 40 % PasteSYed08b690-f907-6d2f-e053-2a95a90af51c3
1094560ZNO 0.4 MG/MG PasteSYed08b690-f907-6d2f-e053-2a95a90af51c3
1797059ZNO 0.4 MG/MG Paste [Desitin]SYed08b690-f907-6d2f-e053-2a95a90af51c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0061-1699680061011 TUBE in 1 CARTON (69968-0061-1) / 28 g in 1 TUBE1 tube2015-11-160000-00-00NoNoCurrent
69968-0061-2699680061021 TUBE in 1 CARTON (69968-0061-2) / 57 g in 1 TUBE1 tube2015-11-160000-00-00NoNoCurrent
69968-0061-3699680061033 TUBE in 1 CARTON (69968-0061-3) / 136 g in 1 TUBE3 tube2015-11-160000-00-00NoNoCurrent
69968-0061-4699680061041 TUBE in 1 CARTON (69968-0061-4) / 113 g in 1 TUBE1 tube2015-11-160000-00-00NoNoCurrent
69968-0061-5699680061051 TUBE in 1 CARTON (69968-0061-5) / 136 g in 1 TUBE1 tube2015-11-160000-00-00NoNoCurrent
69968-0061-7699680061073.5 g in 1 POUCH (69968-0061-7) 3.5 g2015-11-160000-00-00NoNoCurrent
69968-0061-969968006109454 g in 1 JAR (69968-0061-9) 454 g2015-11-160000-00-00NoNoCurrent