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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact 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