FDA.reportPublic FDA data

Desitin Daily Defense Zinc Oxide Diaper Rash

Product NDC
69968-0603
11-digit product format
699680603
Labeler code
69968
Product ID
69968-0603_28fd6f2e-9783-5064-e063-6394a90a6fc0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
Substance
ZINC OXIDE
Active strength
130 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 · 10 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 packagepackage69968-0603-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0603-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0603-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0603-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0603-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0603-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0603-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0603-4367a005e9d99…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 Daily Defense Zinc Oxide Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE130 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
349404Internal RxNorm lookup
1090577Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6e0d1a3-e469-4102-916b-d5cc8ca12e73Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69968-0603-12024-11-25Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-22024-11-25Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-42024-11-25Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-52024-11-25Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-12024-07-30Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-22024-07-30Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-42024-07-30Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-52024-07-30Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0603-1Desitin Daily Defense Zinc Oxide Diaper Rash454 g in 1 JARCREAM4546
69968-0603-2Desitin Daily Defense Zinc Oxide Diaper Rash57 g in 1 TUBECREAM576
69968-0603-2Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16
69968-0603-4Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16
69968-0603-4Desitin Daily Defense Zinc Oxide Diaper Rash113 g in 1 TUBECREAM1136
69968-0603-5Desitin Daily Defense Zinc Oxide Diaper Rash136 g in 1 TUBECREAM1366
69968-0603-5Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16
69968-0603-2Johnsons First Touch Baby Gift Set57 g in 1 TUBECREAM57 g130 mg in 1g5
69968-0603-2Johnsons First Touch Baby Gift Set1 in 1 CARTONCREAM130 mg in 1g5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0603-1GM - Gram69968-06036781e7cd-61c3-4750-bf43-e19396cc70fe12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0603DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH (ZINC OXIDE) CREAM [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 7 package rows20241215_b6e0d1a3-e469-4102-916b-d5cc8ca12e73.zip
69968-0603JOHNSONS FIRST TOUCH BABY GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC20241127_da5469ea-3330-4f04-e053-2a95a90aff41.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090577Desitin 13 % Topical CreamPSNb6e0d1a3-e469-4102-916b-d5cc8ca12e736
349404zinc oxide 13 % Topical CreamPSNb6e0d1a3-e469-4102-916b-d5cc8ca12e736
1090577zinc oxide 130 MG/ML Topical Cream [Desitin]SBDb6e0d1a3-e469-4102-916b-d5cc8ca12e736
349404zinc oxide 130 MG/ML Topical CreamSCDb6e0d1a3-e469-4102-916b-d5cc8ca12e736
1090577Desitin 130 MG/ML Topical CreamSYb6e0d1a3-e469-4102-916b-d5cc8ca12e736
1090577Desitin Rapid Relief 13 % Topical CreamSYb6e0d1a3-e469-4102-916b-d5cc8ca12e736
349404zinc oxide 13 % Topical CreamSYb6e0d1a3-e469-4102-916b-d5cc8ca12e736
349404ZNO 130 MG/ML Topical CreamSYb6e0d1a3-e469-4102-916b-d5cc8ca12e736
1090577ZNO 130 MG/ML Topical Cream [Desitin]SYb6e0d1a3-e469-4102-916b-d5cc8ca12e736
1090577Desitin 13 % Topical CreamPSNda5469ea-3330-4f04-e053-2a95a90aff415
349404zinc oxide 13 % Topical CreamPSNda5469ea-3330-4f04-e053-2a95a90aff415
1090577zinc oxide 130 MG/ML Topical Cream [Desitin]SBDda5469ea-3330-4f04-e053-2a95a90aff415
349404zinc oxide 130 MG/ML Topical CreamSCDda5469ea-3330-4f04-e053-2a95a90aff415
1090577Desitin 130 MG/ML Topical CreamSYda5469ea-3330-4f04-e053-2a95a90aff415
1090577Desitin Rapid Relief 13 % Topical CreamSYda5469ea-3330-4f04-e053-2a95a90aff415
349404zinc oxide 13 % Topical CreamSYda5469ea-3330-4f04-e053-2a95a90aff415
349404ZNO 130 MG/ML Topical CreamSYda5469ea-3330-4f04-e053-2a95a90aff415
1090577ZNO 130 MG/ML Topical Cream [Desitin]SYda5469ea-3330-4f04-e053-2a95a90aff415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0603-169968060301454 g in 1 JAR (69968-0603-1) 454 g2018-12-010000-00-00NoNoCurrent
69968-0603-2699680603021 TUBE in 1 CARTON (69968-0603-2) / 57 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent
69968-0603-4699680603041 TUBE in 1 CARTON (69968-0603-4) / 113 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent
69968-0603-5699680603051 TUBE in 1 CARTON (69968-0603-5) / 136 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent