FDA.reportPublic FDA data

Astonea Chest Rub

Product NDC
77338-321
Requested package NDC
77338-321-21
11-digit product format
773380321
Labeler code
77338
Product ID
77338-321_e81a4c38-108e-1f15-e053-2995a90aedc1
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (synthetic), Eucalyptus oil, and Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-04-05
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL
Active strength
0 g/g; g/g; g/g
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 packagepackage77338-32177338-321-21IInactivated 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 packagepackage77338-32177338-321-21IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-32177338-321-21IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-32177338-321-21IInactivated 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-321-212024-06-25C16284748780-11030e365-0e0e-111a-e063-dadaa90a10e2ASTONEA ChestRub
77338-321-212024-01-30C16284748780-11030e365-0e0e-111a-e063-dadaa90a10e2ASTONEA ChestRub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-321-21Astonea Chest Rub113 g in 1 JAROINTMENT1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-321ASTONEA CHEST RUB (CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_e81a4c38-108d-1f15-e053-2995a90aedc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003749camphor 4.7 % / eucalyptus oil 1.2 % / menthol 1.25 % Topical OintmentPSNe81a4c38-108d-1f15-e053-2995a90aedc12
2003749camphor 0.047 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.0125 MG/MG Topical OintmentSCDe81a4c38-108d-1f15-e053-2995a90aedc12
2003749camphor 4.7 % / eucalyptus oil 1.2 % / menthol 1.25 % Topical OintmentSYe81a4c38-108d-1f15-e053-2995a90aedc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-321-2177338032121113 g in 1 JAR (77338-321-21) 113 g2019-04-080000-00-00NoNoCurrent