DEEP REMEDY

Product NDC: 61577-3610
Requested package NDC: 61577-3610-1
11-digit product format: 615773610
Labeler code: 61577
Product ID: 61577-3610_7af0ed5a-07a7-4ef9-a1c6-c316f9e8314c
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: 2021-12-23
Marketing end: 0000-00-00
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: 0 g/g; g/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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	61577-3610	61577-3610-1	I	Inactivated by FDA		2026-10-16

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 · 13 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…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61577-3610-1	2025-01-30	Deep Remedy Natural Pain Relieving Gel
61577-3610-2	2025-01-30	Deep Remedy Natural Pain Relieving Gel
61577-3610-4	2025-01-30	Deep Remedy Natural Pain Relieving Gel
61577-3610-5	2025-01-30	Deep Remedy Natural Pain Relieving Gel
61577-3610-8	2025-01-30	Deep Remedy Natural Pain Relieving Gel
61577-3610-1	2021-12-27	Deep Remedy Natural Pain Relieving Gel
61577-3610-2	2021-12-27	Deep Remedy Natural Pain Relieving Gel
61577-3610-4	2021-12-27	Deep Remedy Natural Pain Relieving Gel
61577-3610-5	2021-12-27	Deep Remedy Natural Pain Relieving Gel
61577-3610-8	2021-12-27	Deep Remedy Natural Pain Relieving Gel
61577-3610-1	2020-01-31	Deep Remedy Natural Pain Relieving Gel
61577-3610-2	2020-01-31	Deep Remedy Natural Pain Relieving Gel
61577-3610-4	2020-01-31	Deep Remedy Natural Pain Relieving Gel
61577-3610-5	2020-01-31	Deep Remedy Natural Pain Relieving Gel
61577-3610-8	2020-01-31	Deep Remedy Natural Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61577-3610-1	DEEP REMEDY	14.2 g in 1 JAR	GEL	14.2	3
61577-3610-2	DEEP REMEDY	58.7 g in 1 JAR	GEL	58.7	3
61577-3610-4	DEEP REMEDY	113.4 g in 1 JAR	GEL	113.4	3
61577-3610-5	DEEP REMEDY	5 g in 1 POUCH	GEL	5	3
61577-3610-8	DEEP REMEDY	226.8 g in 1 JAR	GEL	226.8	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CAPSICUM	INACTIVE INGREDIENT	00UK7646FG	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
FILIPENDULA ULMARIA FLOWER	INACTIVE INGREDIENT	06L18L32G6	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GRAPEFRUIT SEED OIL	INACTIVE INGREDIENT	598D944HOL	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ORANGE PEEL	INACTIVE INGREDIENT	TI9T76XD44	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
YUCCA SCHIDIGERA ROOT	INACTIVE INGREDIENT	E2H9ET15AT	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-3610	DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	3	Legacy NDC, 5 package rows	20211228_dcfd0511-39d9-4221-b111-947f0785e043.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	dcfd0511-39d9-4221-b111-947f0785e043	3
630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD	dcfd0511-39d9-4221-b111-947f0785e043	3
630714	camphor 3 % / menthol 3 % Topical Gel	SY	dcfd0511-39d9-4221-b111-947f0785e043	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-3610-1	61577361001	14.2 g in 1 JAR (61577-3610-1)	14.2 g	2021-12-23	0000-00-00	No	No	Current