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
LabelManufacturerEffective dateType
321 Cool Pain ReliefSOMBRA COSMETICS INC.2026-04-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3103-1SOMBRA COOL THERAPY85.05 g in 1 TUBEGEL85.0512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ASOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ASOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
LEMON PEELINACTIVE INGREDIENT72O054U628SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
WITCH HAZELINACTIVE INGREDIENT101I4J0U34SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATSOMBRA 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 3 of 235 · 4,693 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Rhinoost SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a296baa-c101-3192-e063-6394a90aa2b02026-08-29WarningsExact identifier
unii: L7T10EIP3A
LUCKSKY SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a29ee19-8b6d-b4fa-e063-6394a90ad81d2026-08-29WarningsExact identifier
unii: L7T10EIP3A
Flobow SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a2aa169-90b5-417f-e063-6394a90aa2782026-08-29WarningsExact identifier
unii: L7T10EIP3A
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Hoxlbin SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a17b116-d573-1c4a-e063-6394a90a499b2026-08-28WarningsExact identifier
unii: L7T10EIP3A
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
unii: 101I4J0U34
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: L7T10EIP3A
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
unii: 101I4J0U34

Reported adverse events (FAERS/openFDA)#

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