FDA.reportPublic FDA data

CALMING DIAPER RASH

Product NDC
52915-069
Requested package NDC
52915-069-05
11-digit product format
529150069
Labeler code
52915
Product ID
52915-069_6afed5fe-19a2-4e43-ab89-57eed6097e5a
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
ORGANIC & SUSTAINABLE BEAUTY
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-31
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
120 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52915-06952915-069-05IInactivated by FDA2026-10-21

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52915-069-052025-01-30C16284748780-12cef2736-86b1-d83d-e063-dadaa90ab31fCALMING DIAPER RASH OINTMENT
52915-069-292025-01-30C16284748780-12cef2736-86b1-d83d-e063-dadaa90ab31fCALMING DIAPER RASH OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-069-05CALMING DIAPER RASH14 g in 1 TUBECREAM141
52915-069-29CALMING DIAPER RASH82 g in 1 TUBECREAM821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-069CALMING DIAPER RASH (ZINC OXIDE) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1Legacy NDC, 2 package rows20201107_002af62f-0e47-4976-82da-b61e89989983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417994zinc oxide 12 % Topical CreamPSN002af62f-0e47-4976-82da-b61e899899831
417994zinc oxide 120 MG/ML Topical CreamSCD002af62f-0e47-4976-82da-b61e899899831
417994zinc oxide 12 % Topical CreamSY002af62f-0e47-4976-82da-b61e899899831
417994ZNO 120 MG/ML Topical CreamSY002af62f-0e47-4976-82da-b61e899899831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52915-069-055291500690514 g in 1 TUBE (52915-069-05) 14 g2015-08-310000-00-00NoNoCurrent