FDA.reportPublic FDA data

ASTONEA

Product NDC
77338-304
Requested package NDC
77338-304-05
11-digit product format
773380304
Labeler code
77338
Product ID
77338-304_e68b3524-ed6f-55ec-e053-2995a90ab29c
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
2013-05-23
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
20 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 packagepackage77338-30477338-304-05IInactivated 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 packagepackage77338-30477338-304-05IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-30477338-304-05IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-30477338-304-05IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
77338-304-032026-01-29ASTONEA Zinc oxide 20%
77338-304-042026-01-29ASTONEA Zinc oxide 20%
77338-304-052026-01-29ASTONEA Zinc oxide 20%
77338-304-032024-06-25ASTONEA Zinc oxide 20%
77338-304-042024-06-25ASTONEA Zinc oxide 20%
77338-304-052024-06-25ASTONEA Zinc oxide 20%
77338-304-032024-01-30ASTONEA Zinc oxide 20%
77338-304-042024-01-30ASTONEA Zinc oxide 20%
77338-304-052024-01-30ASTONEA Zinc oxide 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-304-03ASTONEA28.3 g in 1 TUBEOINTMENT28.32
77338-304-04ASTONEA56.6 g in 1 TUBEOINTMENT56.62
77338-304-05ASTONEA425 g in 1 JAROINTMENT4252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-304ASTONEA (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 3 package rows20240627_e68b34ea-0cb3-574f-e053-2995a90ad828.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNe68b34ea-0cb3-574f-e053-2995a90ad8282
198911zinc oxide 0.2 MG/MG Topical OintmentSCDe68b34ea-0cb3-574f-e053-2995a90ad8282
198911zinc oxide 20 % Topical OintmentSYe68b34ea-0cb3-574f-e053-2995a90ad8282
198911zinc oxide 200 MG per GM Topical OintmentSYe68b34ea-0cb3-574f-e053-2995a90ad8282
198911ZNO 0.2 MG/MG Topical OintmentSYe68b34ea-0cb3-574f-e053-2995a90ad8282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-304-0577338030405425 g in 1 JAR (77338-304-05) 425 g2013-05-230000-00-00NoNoCurrent