NDC 61577-3100-01 - SOMBRA WARM THERAPY

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 61577-3100
Requested NDC: 61577-3100-01
Package NDCs from labels: 61577-3100-1, 61577-3100-01
Manufacturer: SOMBRA COSMETICS INC.
Effective date: 2026-04-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Santa Calma Plus Warming Pain Relief	SOMBRA COSMETICS INC.	2026-04-24	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-3100-1	SOMBRA WARM THERAPY	226.7 g in 1 JUG	GEL	226.7		16

DailyMed Socrata Ingredients#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 237 · 4,729 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
REINREUDE SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a539219-f9b8-5e94-e063-6294a90a2593	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
SERYNTH SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a5405f9-9881-e547-e063-6294a90a0d10	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	HyVee Inc	53157137-b980-45d2-aa10-8c111c0ec2f4	2026-08-31	Warnings	Exact identifier application number: M017
EAYONYUMT NECK PAIN RELIEF	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a450e68-07a7-a4bb-e063-6294a90a97c9	2026-08-30	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a458280-4f9c-5af6-e063-6394a90acb2e	2026-08-30	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a45d19f-c753-71eb-e063-6294a90a4805	2026-08-30	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin	HYDROCORTISONE	AmerisourceBergen	c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495	2026-08-30	Warnings	Exact identifier application number: M017
SYLVIRENE SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a4fd689-2113-f15a-e063-6394a90a45ad	2026-08-30	Warnings	Exact identifier unii: L7T10EIP3A
Rhinoost SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a296baa-c101-3192-e063-6394a90aa2b0	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
LUCKSKY SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a29ee19-8b6d-b4fa-e063-6394a90ad81d	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
Flobow SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a2aa169-90b5-417f-e063-6394a90aa278	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
Olu Pain Management	LIDOCAINE AND CAMPHOR	HAWAII REPACK, INC.	31ed3d82-ba12-46b2-b0ec-7e5e019efc10	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a177987-7c05-f07f-e063-6394a90aa9ba	2026-08-28	Warnings	Exact identifier application number: M017
Hoxlbin SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a17b116-d573-1c4a-e063-6394a90a499b	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
Norms Hemorrhoid Wipes	WITCH HAZEL	Totally Normal Company	5a1af50b-8d00-f589-e063-6394a90af86c	2026-08-28	Warnings	Exact identifier unii: 101I4J0U34
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
Relieved Pro Wrap	4% LIDOCAINE PATCH	Transfer Technology	5a1c6ebf-ad3f-c47b-e063-6294a90aa19a	2026-08-28	Warnings	Exact identifier application number: M017
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: 5TJD82A1ET

Reported adverse events (FAERS/openFDA)#

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