FDA.reportPublic FDA data

SOMBRA COOL THERAPY

Product NDC
61577-3103
11-digit product format
615773103
Labeler code
61577
Product ID
61577-3103_4ffb85fd-c60e-3f70-e063-6294a90a6fdc
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-21
Substance
MENTHOL
Active strength
.06 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SOMBRA COOL THERAPY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.06 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415976Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3Available on FDA.report

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 65 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Cold As Ice Pain ReliefMENTHOLTelebrands Corp95e84bb9-ba2e-5009-e053-2995a90a43622025-11-12WarningsExact identifier
application number: M017
LidozallLIDOCAINE HYDROCHLORIDEV2 Pharma LLC1eb2dfb2-3ad1-488b-aed9-17220e34a10c2025-11-12WarningsExact identifier
application number: M017
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
application number: M017
Knee Pain Relief PatchDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATEShenzhen Finona Information Technology Co., Ltd38755738-1a06-fdb4-e063-6294a90aa6eb2025-11-12WarningsExact identifier
application number: M017
Recovery NumbLIDOCAINE 4%PURKLENZ FORMULATIONS INC.e95e38e3-f743-4f5c-abdf-99ba6856e6f72025-11-12WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED434c13c2-52ee-000f-e063-6294a90af7e72025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED434d5f92-05c2-d884-e063-6394a90ad28c2025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434df0be-49ff-aa56-e063-6394a90a3b5a2025-11-11WarningsExact identifier
application number: M017
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
application number: M017
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
application number: M017
A and E Marathon Delay SerumDELAY SERUMPhe Inc4355d1d8-44fe-aca1-e063-6294a90a85ff2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
application number: M017
A and E Easy Anal GelANAL NUMBING LUBRICANTPhe Inc4355e0f3-65ba-eca6-e063-6394a90ab43c2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayPeppermintORAL NUMBING SPRAY MINTPhe Inc4355e0d0-1222-d594-e063-6294a90abb292025-11-11WarningsExact identifier
application number: M017
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
application number: M017
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415976menthol 6 % Topical GelPSN87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca312
415976menthol 0.06 MG/MG Topical GelSCD87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca312
415976menthol 6 % Topical GelSY87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61577-3103-16157731030185.05 g in 1 TUBE (61577-3103-1) 85.05 g2026-04-21NoNoCurrent