Menthol 5% Hydrogel

Product NDC: 71391-127
Requested package NDC: 71391-127-05
11-digit product format: 713910127
Labeler code: 71391
Product ID: 71391-127_3d7db013-d5f0-4742-8e63-ac5195ce3db1
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: 2020-10-01
Marketing end: 0000-00-00
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 600 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	71391-127	71391-127-05	D	Discontinued by firm		2026-10-05

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 · 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	71391-127	71391-127-05	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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71391-127-05	Menthol 5% Hydrogel	5 in 1 POUCH	PATCH	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71391-127	MENTHOL 5% HYDROGEL (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20250115_3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1.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
420222	menthol 5 % Medicated Patch	PSN	3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1	3
420222	menthol 0.05 MG/MG Medicated Patch	SCD	3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1	3
420222	menthol 5 % Medicated Patch	SY	3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71391-127-05	71391012705	5 PATCH in 1 POUCH (71391-127-05)	5 patch	2020-10-01	0000-00-00	No	No	Current