Body

Product NDC: 55301-379
Requested package NDC: 55301-379-38
11-digit product format: 553010379
Labeler code: 55301
Product ID: 55301-379_1af7b681-1cef-4645-a527-c6ce387bfe65
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: POWDER
Route: TOPICAL
Labeler: Exchange Select
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-11-30
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55301-379	55301-379-38	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
GUM TALHA	INACTIVE INGREDIENT	H18F76G097	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	BODY (MENTHOL, ZINC OXIDE) POWDER [EXCHANGE SELECT]	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55301-379-38	55301037938	283 g in 1 BOTTLE (55301-379-38)	283 g	2013-11-30	0000-00-00	No	No	Current