FDA.reportPublic FDA data

Astonea

Product NDC
77338-306
Requested package NDC
77338-306-64
11-digit product format
773380306
Labeler code
77338
Product ID
77338-306_ef7c1a32-f72a-3c5a-e053-2995a90abd43
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-02-07
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
4 g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77338-30677338-306-64IInactivated 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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-30677338-306-64IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-30677338-306-64IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-30677338-306-64IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-306-642024-06-25C16284748780-11030e365-692e-111a-e063-dadaa90a10e2Astonea Skin Enshield
77338-306-642024-01-30C16284748780-11030e365-692e-111a-e063-dadaa90a10e2Astonea Skin Enshield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-306-64AstoneaEN SHIELD ALOE SOFT VITAMIN ENRICHED99.2 g in 1 TUBECREAM99.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-306ASTONEA EN SHIELD ALOE SOFT VITAMIN ENRICHED (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_ef7c1864-336d-c402-e053-2a95a90a8740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089065zinc oxide 3.8 % Topical OintmentPSNef7c1864-336d-c402-e053-2a95a90a87402
1089065zinc oxide 0.038 MG/MG Topical OintmentSCDef7c1864-336d-c402-e053-2a95a90a87402
1089065ZNO 0.038 MG/MG Topical OintmentSYef7c1864-336d-c402-e053-2a95a90a87402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-306-647733803066499.2 g in 1 TUBE (77338-306-64) 99.2 g2020-02-070000-00-00NoNoCurrent