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 60 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact 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