Menthol

Product NDC: 71391-128
Requested package NDC: 71391-128-05
11-digit product format: 713910128
Labeler code: 71391
Product ID: 71391-128_b8ee1003-ec8c-4c59-9e02-1cad729e1ef7
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: PATCH
Route: TOPICAL
Labeler: Unexo Life Sciences Private Limited
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2022-11-15
Marketing end: 0000-00-00
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 105 mg/1
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71391-128	71391-128-05	D	Discontinued by firm		2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71391-128	71391-128-05	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71391-128-01	Menthol	1 in 1 POUCH	PATCH	1		2
71391-128-05	Menthol	5 in 1 BOX	PATCH	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71391-128	MENTHOL (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES PRIVATE LIMITED]	2	Legacy NDC, 2 package rows	20250115_c991cc06-cb3a-4e6a-9595-f689c8fa63b6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010823	menthol 7.5 % Medicated Patch	PSN	c991cc06-cb3a-4e6a-9595-f689c8fa63b6	2
1010823	menthol 0.075 MG/MG Medicated Patch	SCD	c991cc06-cb3a-4e6a-9595-f689c8fa63b6	2
1010823	menthol 7.5 % Medicated Patch	SY	c991cc06-cb3a-4e6a-9595-f689c8fa63b6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71391-128-05	71391012805	5 POUCH in 1 BOX (71391-128-05) > 1 PATCH in 1 POUCH (71391-128-01)	5 pouch	2022-11-15	0000-00-00	No	No	Current