DR WOLFES COOL THERAPY

Product NDC: 61577-1020
Requested package NDC: 61577-1020-4
11-digit product format: 615771020
Labeler code: 61577
Product ID: 61577-1020_9a63f326-6b6c-d05b-e053-2a95a90a3919
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: SOMBRA COSMETICS INC.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-05-29
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 0 g/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	61577-1020	61577-1020-4	I	Inactivated by FDA		2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61577-1020-4	2025-01-30	C162847	48780-1	f386c649-9cf1-0266-e053-dadaa90a7c1a	Dr Wolfes Cool Therapy
61577-1020-4	2023-03-09	C162847	48780-1	f386c649-9cf1-0266-e053-dadaa90a7c1a	Dr Wolfes Cool Therapy
61577-1020-4	2023-01-30	C162847	48780-1	f386c649-9cf1-0266-e053-dadaa90a7c1a	Dr Wolfes Cool Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-1020-4	DR WOLFES COOL THERAPY	113.4 g in 1 JAR	GEL	113.4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-1020	DR WOLFES COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	3	Legacy NDC, 1 package rows	20230310_119314c2-f9ad-4b39-abd4-8f8cc6fadeaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415976	menthol 6 % Topical Gel	PSN	119314c2-f9ad-4b39-abd4-8f8cc6fadeaf	3
415976	menthol 0.06 MG/MG Topical Gel	SCD	119314c2-f9ad-4b39-abd4-8f8cc6fadeaf	3
415976	menthol 6 % Topical Gel	SY	119314c2-f9ad-4b39-abd4-8f8cc6fadeaf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-1020-4	61577102004	113.4 g in 1 JAR (61577-1020-4)	113.4 g	2019-05-29	0000-00-00	No	No	Current