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 7 of 235 · 4,693 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving Cream Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Garcoa, Inc.	2f736307-5cd4-4a76-9044-4aeecba096cc	2026-08-18	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Lidocaine Pain Relief Roll on	PAIN RELIEF ROLL ON	NeilMed Pharmaceuticals Inc	58ff9d2d-99e6-8f98-e063-6394a90a8de7	2026-08-17	Warnings	Exact identifier application number: M017
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier unii: PDC6A3C0OX
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1/2%	Sun Pharmaceutical Industries, Inc.	59337940-c9be-58af-e063-6394a90abe13	2026-08-16	Warnings	Exact identifier application number: M017
SIERQ Numbing	MENTHOL	Putian Licheng District Zhijiancheng Trading Co., Ltd.	5936c070-d8e4-56e8-e063-6294a90a5600	2026-08-16	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5911d9b0-1acb-3546-e063-6294a90adb3a	2026-08-15	Warnings	Exact identifier application number: M017 unii: L7T10EIP3A
Foot Pain Relief Gel-Patch	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	49220240-5410-eb6d-e063-6394a90a1328	2026-08-14	Warnings	Exact identifier unii: L7T10EIP3A
BM BM63 DROPS	CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN	BM Private Limited	59006d82-610a-2e08-e063-6394a90af1ed	2026-08-14	Warnings	Exact identifier unii: 059QF0KO0R
BM BM164 DROPS	ARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUM	BM Private Limited	5902770f-eb01-d099-e063-6394a90ad3eb	2026-08-14	Warnings	Exact identifier unii: PDC6A3C0OX
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	59072f05-eefa-d823-e063-6394a90a0e1a	2026-08-14	Warnings	Exact identifier application number: M017
Best Health Caramel Apple Cough Drops	MENTHOL	Bestco	58eee9b4-d696-995f-e063-6294a90a5db0	2026-08-13	Warnings	Exact identifier unii: L7T10EIP3A
Best Health Pumpkin Spice Cough Drops	MENTHOL	Bestco	58ef6619-9087-5f41-e063-6294a90a7da6	2026-08-13	Warnings	Exact identifier unii: L7T10EIP3A
Best Health Bourbon Honey Cough Drops	MENTHOL	Bestco	58efdf29-83ea-03b9-e063-6294a90ad306	2026-08-13	Warnings	Exact identifier unii: L7T10EIP3A
JJ Care First Aid Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Nantong Health & Beyond Hygienic Products Inc.	c41621fb-c549-4394-a4cb-cb81ef8c98df	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	35b5ba9d-da1d-55d6-e063-6294a90a5fa8	2026-08-12	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine numbing cream	5% LIDOCAINE	100 KARMA INC	47380721-6633-4a50-e063-6394a90aca94	2026-08-12	Warnings	Exact identifier unii: L7T10EIP3A
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	47dc7630-9a74-1989-e063-6294a90a50bb	2026-08-12	Warnings	Exact identifier unii: L7T10EIP3A
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Exact identifier application number: M017

Reported adverse events (FAERS/openFDA)#

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