HealQu Warm Therapy Gel

Product NDC: 61577-4080
Requested package NDC: 61577-4080-1
11-digit product format: 615774080
Labeler code: 61577
Product ID: 61577-4080_a033b9ae-b187-7962-e053-2a95a90a3e25
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL CAMPHOR
Dosage form: GEL
Route: TOPICAL
Labeler: SOMBRA COSMETICS INC.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-07-02
Marketing end: 0000-00-00
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: 0 g/g; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61577-4080	61577-4080-1	I	Inactivated by FDA		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 · 10 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…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	HealQu Warm Therapy Gel
2023-03-09	HealQu Warm Therapy Gel
2023-01-30	HealQu Warm Therapy Gel
2020-03-06	HealQu Warm Therapy Gel
2020-01-31	HealQu Warm Therapy Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-4080-1	HealQu Warm Therapy Gel	226.8 g in 1 JAR	GEL	226.8		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-4080	HEALQU WARM THERAPY GEL (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4	Legacy NDC, 1 package rows	20230311_63ac4535-2114-4f4f-83cf-0f88aeff511b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630714	camphor 3 % / menthol 3 % Topical Gel	PSN	63ac4535-2114-4f4f-83cf-0f88aeff511b	4
1927297	HEALQU warm therapy 3 % / 3 % Topical Gel	PSN	63ac4535-2114-4f4f-83cf-0f88aeff511b	4
1927297	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel [Healqu]	SBD	63ac4535-2114-4f4f-83cf-0f88aeff511b	4
630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD	63ac4535-2114-4f4f-83cf-0f88aeff511b	4
630714	camphor 3 % / menthol 3 % Topical Gel	SY	63ac4535-2114-4f4f-83cf-0f88aeff511b	4
1927297	HealQu (camphor 3 % / menthol 3 % ) Topical Gel	SY	63ac4535-2114-4f4f-83cf-0f88aeff511b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-4080-1	61577408001	226.8 g in 1 JAR (61577-4080-1)	226.8 g	2017-07-02	0000-00-00	No	No	Current