FDA.reportPublic FDA data

ASTONEA Medicated Body Powder

Product NDC
77338-403
11-digit product format
773380403
Labeler code
77338
Product ID
77338-403_e69b4081-ef32-78be-e053-2995a90a52e4
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, ZINC OXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-10-05
Marketing end
0000-00-00
Substance
MENTHOL; ZINC OXIDE
Active strength
0 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77338-403IInactivated by FDA2026-10-05
excluded packagepackage77338-40377338-403-10IInactivated by FDA2026-10-05

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-403-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-403-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-403-101332a3947898…d4bfe170f9cd…

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
77338-403-102024-06-25C16284748780-11030e365-5312-111a-e063-dadaa90a10e2Astonea Medicated Body Powder
77338-403-102024-01-30C16284748780-11030e365-5312-111a-e063-dadaa90a10e2Astonea Medicated Body Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-403-10ASTONEA Medicated Body PowderPowder283 g in 1 BOTTLEPOWDER2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-403ASTONEA MEDICATED BODY POWDER POWDER (MENTHOL, ZINC OXIDE) POWDER [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_e69b4924-313b-0ea5-e053-2995a90a616d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSNe69b4924-313b-0ea5-e053-2995a90a616d2
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCDe69b4924-313b-0ea5-e053-2995a90a616d2
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSYe69b4924-313b-0ea5-e053-2995a90a616d2
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSYe69b4924-313b-0ea5-e053-2995a90a616d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-403-1077338040310283 g in 1 BOTTLE (77338-403-10) 283 g2021-10-050000-00-00NoNoCurrent