FDA.reportPublic FDA data

Astonea

Product NDC
77338-802
Requested package NDC
77338-802-00
11-digit product format
773380802
Labeler code
77338
Product ID
77338-802_e5d284fc-a71a-a598-e053-2a95a90a539a
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-09
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
4 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77338-80277338-802-00IInactivated 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 packagepackage77338-80277338-802-00IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-80277338-802-00IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-80277338-802-00IInactivated 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, Related label table
NDCEffectiveRelated label
77338-802-002024-06-25astonea PeriShield
77338-802-042024-06-25astonea PeriShield
77338-802-002024-01-30astonea PeriShield
77338-802-042024-01-30astonea PeriShield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-802-00AstoneaPeriShield100 g in 1 TUBEOINTMENT1002
77338-802-04AstoneaPeriShield452 g in 1 JAROINTMENT4522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-802ASTONEA PERISHIELD (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 2 package rows20240627_e5d284f3-839e-cd25-e053-2995a90ad479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089065zinc oxide 3.8 % Topical OintmentPSNe5d284f3-839e-cd25-e053-2995a90ad4792
1089065zinc oxide 0.038 MG/MG Topical OintmentSCDe5d284f3-839e-cd25-e053-2995a90ad4792
1089065ZNO 0.038 MG/MG Topical OintmentSYe5d284f3-839e-cd25-e053-2995a90ad4792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-802-0077338080200100 g in 1 TUBE (77338-802-00) 100 g2022-08-090000-00-00NoNoCurrent