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 56 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unilevera735d885-bacd-0f5c-e053-2a95a90ad14a2024-10-24WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZERConopco Inc. d/b/a/ Unileverb8dc481c-1ac3-2d63-e053-2a95a90a44f52024-10-24WarningsExact identifier
application number: M016
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverd1039316-3ca8-90f8-e053-2995a90a20612024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.130d94d8-ad98-d61f-e063-6294a90a76b02024-10-21WarningsExact identifier
application number: M016
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
application number: M016
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
application number: M016
PETROLEUMWHITE PETROLATUMVIVE HEALTH LLC24ae3875-1c86-c7ba-e063-6394a90a67292024-10-17WarningsExact identifier
application number: M016
Meijer Skin Relieving MoisturizingDIMETHICONEMEIJER DISTRIBUTION, INC8e5be6b3-87e7-d958-e053-2a95a90a69612024-10-16WarningsExact identifier
application number: M016
GenRx Daily Defense Skin RepairingDIMETHICONEPureTek Corporation7d2827fd-b40f-454b-bb60-54d77823b18c2024-10-16WarningsExact identifier
application number: M016
Equate Daily Moisturizing Dimethicone Skin ProtectantDIMETHICONEWalmart Stores Inc.8fda01f7-a52a-4a63-98ac-b32cb47947f32024-10-16WarningsExact identifier
application number: M016
Hill Country EssentialsDIMETHICONEH.E.Bc51d8647-8af6-473a-b989-dfa6bfdc368d2024-10-15WarningsExact identifier
application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTEDWHITE PETROLEUMUniversal Distribution Center LLC649e571f-0cd6-41e4-b31f-c818f94fb01d2024-10-15WarningsExact identifier
application number: M016
WALGREENS ECZEMACOLLOIDAL OATMEALWALGREEN COMPANYfc502963-4cb6-5ce5-e053-6394a90a58c32024-10-14WarningsExact 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