NDC 61577-3103-01 - SOMBRA COOL 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: 61577-3103
Requested NDC: 61577-3103-01
Package NDCs from labels: 61577-3103-1, 61577-3103-01
Manufacturer: SOMBRA COSMETICS INC.
Effective date: 2026-04-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
321 Cool Pain Relief	SOMBRA COSMETICS INC.	2026-04-21	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-3103-1	SOMBRA COOL THERAPY	85.05 g in 1 TUBE	GEL	85.05		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
FILIPENDULA ULMARIA FLOWER	INACTIVE INGREDIENT	06L18L32G6	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GRAPEFRUIT SEED OIL	INACTIVE INGREDIENT	598D944HOL	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
LEMON PEEL	INACTIVE INGREDIENT	72O054U628	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
YUCCA SCHIDIGERA ROOT	INACTIVE INGREDIENT	E2H9ET15AT	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1

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 2 of 235 · 4,693 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flushable Hemorrhoidal Medicated Wipes Maximum Strength	WITCH HAZEL	Amazon.com Services LLC	41d756f3-e523-ed14-e063-6394a90ab817	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	HEMORRHOIDAL WIPES WITH WITCH HAZEL	Better Living Brands LLC	adf26111-70ba-596c-e053-2995a90ac6f1	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
up and up medicated wipes manixim strength	GENTLE HEMORRHOIDAL CARE	Target Corporation	271eab2b-ed13-39f1-e054-00144ff88e88	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE	WITCH HAZEL CLOTH	The Kroger Co.	48c1598d-6667-446f-ac90-10ab945d0617	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel	WITCH HAZEL	Old East Main Co.	2055289d-962e-46a9-b371-b5bb93dd46b4	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
Equate Hemorrhoidal Medicated Wipes	WITCH HAZEL	Walmart Inc.	8d57f054-77dc-4205-85f1-b65dcfde677b	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 101I4J0U34
Equate Menthol Pain Relieving	MENTHOL	Wal-Mart Stores Inc	d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc	2026-09-03	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
ZHI Technologies	LIDOCAINE, MENTHOL	ZHI Technologies, Inc.	6717e995-4d2d-49e8-8ecf-7c62557dfdef	2026-09-03	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Komxsum LIDOCAINE Cream	LIDOCAINE 4% CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9feae0-9be4-e736-e063-6294a90abe55	2026-09-03	Warnings	Exact identifier application number: M017
FREEZE EASE Roll-On	MENTHOL	Global America Group LLC	1869cc0d-a056-45de-aede-23b09b61ed12	2026-09-02	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Gaimoa Lidocaine Pain Relief Gel Patches	LIDOCAINE PAIN RELIEF GEL PATCHES	Henan Enokon Medical Instrument Co., Ltd.	5a68fe67-5c15-af9a-e063-6294a90a7ec1	2026-09-01	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
CVS Cortisone Liquid	HYDROCORTISONE	CVS Pharmacy	42df45a9-d449-090a-e063-6394a90a9ee4	2026-09-01	Warnings	Exact identifier application number: M017
Ramedica Herbal Wonder Balm	CAMPHOR, MENTHOL	Ramedicare Sdn. Bhd.	cfb2ea0e-a1f6-4fdf-b866-346bbe78788f	2026-09-01	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
La Vaquita New Regular	METHYL SALICYLATE	Delon Laboratories (1990) Ltd	d62186ac-afbb-443e-98c2-f0d122422a3c	2026-09-01	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
ActivICE	MENTHOL	Medline Industries, LP	834adeb9-38ad-0cfe-e053-2991aa0af82f	2026-09-01	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
La Vaquita New Extra	METHYL SALICYLATE, MENTHOL	Delon Laboratories (1990) Ltd	3097a01b-cee5-492f-b65a-63992fb28e3a	2026-09-01	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier unii: L7T10EIP3A
Terramed Just Think Comfort Hydrocortisone 1% Cream	HYDROCORTISONE	Rida LLC	0d2c0c2c-370f-4adb-b0ea-1e218c927f8b	2026-09-01	Warnings	Exact identifier application number: M017
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier unii: L7T10EIP3A
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

Reported adverse events (FAERS/openFDA)#

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