Desitin Maximum Strength Zinc Oxide Diaper Rash

Product NDC
69968-0396
11-digit product format
699680396
Labeler code
69968
Product ID
69968-0396_26e03d32-1a19-2397-e063-6394a90a8982
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
2018-06-01
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 · 4 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 packagepackage69968-0396-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0396-1367a005e9d99…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 Zinc Oxide 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
59728810-4ea9-45a1-b945-5a54199e01f3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0396-1Desitin Maximum Strength Zinc Oxide Diaper Rash454 g in 1 JARPASTE4545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0396DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 1 package rows20241127_59728810-4ea9-45a1-b945-5a54199e01f3.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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Body Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9d86fc-ef32-baed-e063-6394a90a7d742026-03-12WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797059Desitin 40 % Topical PastePSN59728810-4ea9-45a1-b945-5a54199e01f35
1094560zinc oxide 40 % Topical PastePSN59728810-4ea9-45a1-b945-5a54199e01f35
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD59728810-4ea9-45a1-b945-5a54199e01f35
1094560zinc oxide 0.4 MG/MG PasteSCD59728810-4ea9-45a1-b945-5a54199e01f35
1797059Desitin 40 % Topical PasteSY59728810-4ea9-45a1-b945-5a54199e01f35
1094560zinc oxide 40 % PasteSY59728810-4ea9-45a1-b945-5a54199e01f35
1094560ZNO 0.4 MG/MG PasteSY59728810-4ea9-45a1-b945-5a54199e01f35
1797059ZNO 0.4 MG/MG Paste [Desitin]SY59728810-4ea9-45a1-b945-5a54199e01f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0396-169968039601454 g in 1 JAR (69968-0396-1) 454 g2018-06-010000-00-00NoNoCurrent