FDA.reportPublic FDA data

Menthol and Zinc Oxide

Product NDC
77338-013
11-digit product format
773380013
Labeler code
77338
Product ID
77338-013_e67673ba-333e-6bf6-e053-2a95a90a69fb
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-17
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 productproduct77338-013IInactivated by FDA2026-10-05
excluded packagepackage77338-01377338-013-23IInactivated 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 packagepackage77338-013-238af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-013-23834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-013-231332a3947898…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
77338-013-232024-06-25C16284748780-11030e364-f939-111a-e063-dadaa90a10e2ASTONEA Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant
77338-013-232024-01-30C16284748780-11030e364-f939-111a-e063-dadaa90a10e2ASTONEA Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-013-23Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-013MENTHOL AND ZINC OXIDE OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_e67673ba-333c-6bf6-e053-2a95a90a69fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSNe67673ba-333c-6bf6-e053-2a95a90a69fb2
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDe67673ba-333c-6bf6-e053-2a95a90a69fb2
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYe67673ba-333c-6bf6-e053-2a95a90a69fb2
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSYe67673ba-333c-6bf6-e053-2a95a90a69fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-013-2377338001323113 g in 1 TUBE (77338-013-23) 113 g2022-08-170000-00-00NoNoCurrent