Body

Product NDC
49348-801
Requested package NDC
49348-801-92
11-digit product format
493480801
Labeler code
49348
Product ID
49348-801_5f06a389-d9d6-4f21-b887-c17aa6847603
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, zinc oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
McKesson
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage49348-80149348-801-92DDiscontinued by firm2026-10-16

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
49348-801-922020-07-29C16284748780-19d75b9cf-ce21-f424-e053-dadaa90a57ceSunmark 379.001-379AB
49348-801-922020-01-31C16284748780-19d75b9cf-ce21-f424-e053-dadaa90a57ceSunmark 379.001-379AB

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
MENTHOLACTIVE MOIETYL7T10EIP3ABODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
GUM TALHAINACTIVE INGREDIENTH18F76G097BODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
THYMOLINACTIVE INGREDIENT3J50XA376EBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVBODY (MENTHOL, ZINC OXIDE) POWDER [MCKESSON]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-801-9249348080192283 g in 1 BOTTLE, PLASTIC (49348-801-92) 283 g2013-08-010000-00-00NoNoCurrent