SOMBRA COOL THERAPY

Product NDC: 61577-4030
11-digit product format: 615774030
Labeler code: 61577
Product ID: 61577-4030_a033c021-5750-9c78-e053-2a95a90a09d9
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: 2017-10-20
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 0 g/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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61577-4030		I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-1	I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-2	I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-3	I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-4	I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-5	I	Inactivated by FDA	2026-10-12
excluded package	package	61577-4030	61577-4030-6	I	Inactivated by FDA	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 2 · 70 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61577-4030-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61577-4030-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-4030-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-4030-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-4030-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-4030-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-4030-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-4030-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61577-4030-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61577-4030-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61577-4030-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61577-4030-1	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-2	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-3	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-4	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-5	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-6	2025-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-1	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-2	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-3	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-4	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-5	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-6	2023-03-03	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-1	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-2	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-3	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-4	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-5	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-6	2023-01-30	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-1	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-2	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-3	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-4	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-5	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-6	2020-03-06	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-1	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-2	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-3	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-4	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-5	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada
61577-4030-6	2020-01-31	Sombra Cool Therapy Natural Pain Relieving Gel Canada

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61577-4030-1	SOMBRA COOL THERAPY	3628.7 g in 1 BOTTLE, PUMP	GEL	3628.7	18
61577-4030-2	SOMBRA COOL THERAPY	907.2 g in 1 BOTTLE, PUMP	GEL	907.2	18
61577-4030-3	SOMBRA COOL THERAPY	226.8 g in 1 JAR	GEL	226.8	18
61577-4030-4	SOMBRA COOL THERAPY	113.4 g in 1 JAR	GEL	113.4	18
61577-4030-5	SOMBRA COOL THERAPY	85 g in 1 BOTTLE, PLASTIC	GEL	85	18
61577-4030-6	SOMBRA COOL THERAPY	5 g in 1 POUCH	GEL	5	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-4030	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	18	Legacy NDC, 6 package rows	20230306_a2d403f7-aad0-4692-a36f-ee25a84a013f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415976	menthol 6 % Topical Gel	PSN	a2d403f7-aad0-4692-a36f-ee25a84a013f	18
415976	menthol 0.06 MG/MG Topical Gel	SCD	a2d403f7-aad0-4692-a36f-ee25a84a013f	18
415976	menthol 6 % Topical Gel	SY	a2d403f7-aad0-4692-a36f-ee25a84a013f	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-4030-1	61577403001	3628.7 g in 1 BOTTLE, PUMP (61577-4030-1)	3628.7 g	2017-10-20	0000-00-00	No	No	Current
61577-4030-2	61577403002	907.2 g in 1 BOTTLE, PUMP (61577-4030-2)	907.2 g	2017-10-20	0000-00-00	No	No	Current
61577-4030-3	61577403003	226.8 g in 1 JAR (61577-4030-3)	226.8 g	2017-10-20	0000-00-00	No	No	Current
61577-4030-4	61577403004	113.4 g in 1 JAR (61577-4030-4)	113.4 g	2017-10-20	0000-00-00	No	No	Current
61577-4030-5	61577403005	85 g in 1 BOTTLE, PLASTIC (61577-4030-5)	85 g	2017-10-20	0000-00-00	No	No	Current
61577-4030-6	61577403006	5 g in 1 POUCH (61577-4030-6)	5 g	2017-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sombra Cool Therapy Natural Pain Relieving Gel Canada	SOMBRA COSMETICS INC.	2023-03-03	HUMAN OTC DRUG LABEL	18