FDA.reportPublic FDA data

SOMBRA WARM THERAPY

Product NDC
61577-3100
11-digit product format
615773100
Labeler code
61577
Product ID
61577-3100_503818c4-aafa-b69c-e063-6294a90a034e
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-10
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
.03; .03 g/g; 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 WARM THERAPY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.03 g/g
CAMPHOR (SYNTHETIC).03 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de78dba9-53b3-4dbd-9dd2-6a692378da34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3100-1SOMBRA WARM THERAPY226.7 g in 1 JUGGEL226.716

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
MENTHOLACTIVE INGREDIENTL7T10EIP3ASOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3ASOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CAPSICUMINACTIVE INGREDIENT00UK7646FGSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ORANGE PEELINACTIVE INGREDIENTTI9T76XD44SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
WITCH HAZELINACTIVE INGREDIENT101I4J0U34SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATSOMBRA 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 38 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Muscle and Joint Gel Vanishing ScentMENTHOL 2.5%Veridian Healthcare494d2a85-45a8-12a2-e063-6294a90a391b2026-01-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINETrifecta Pharmaceuticals USA, LLC.493c09d0-16d7-7413-e063-6394a90aa0522026-01-26WarningsExact identifier
application number: M017
Topcare Medicated Pain Relieving Patch 60ctTOPCARE PAIN RELIEF PATCH EXTRA STRENGTHTopco Associates LLC4953c12b-ca6d-d21e-e063-6294a90ac9902026-01-26WarningsExact identifier
application number: M017
Dr SabharwalsMENTHOL 5% PATCHDr. Sabharwal's Wound Care1025b986-a1e5-701d-e063-6294a90a33fd2026-01-24WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical AnalgesicMENTHOLTarget Corporation4910f32f-c639-0215-e063-6394a90a1c7b2026-01-23WarningsExact identifier
application number: M017
RapidolHYDROCORTISONEPharmadel LLC19a1f1e2-bc6b-7153-e063-6294a90ab1152026-01-23WarningsExact identifier
application number: M017
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct LargeLIDOCAINECVS PHARMACY, INC4914965f-1164-e20e-e063-6294a90ac2212026-01-23WarningsExact identifier
application number: M017
THE GOO MEDICATED PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAPSM PERFORMANCE, LLCdb4c321c-8cdc-5a11-e053-2995a90a91a12026-01-23WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% AND MENTHOL 1% PATCHDr. Sabharwal's Wound Care10249d0f-5ee1-6892-e063-6394a90a967e2026-01-23WarningsExact identifier
application number: M017
Easment DMSO creamMENTHOL 1.00%Easment LLC48f5544e-1cfd-864a-e063-6394a90a71f12026-01-22WarningsExact identifier
application number: M017
Aveeno 1% Hydrocortisone Anti-Itch CreamHYDROCORTISONEKenvue Brands LLC1ac0ac4e-af76-9a3e-e063-6394a90a12692026-01-22WarningsExact identifier
application number: M017
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M017
X-Treme FreezeCOLD THERAPY GELDynarex Corporation79f0802f-03ad-bf8f-e053-2991aa0ae4b52026-01-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONEHyVee Incae31f1f5-db70-45cf-850e-67bfe68607482026-01-21WarningsExact identifier
application number: M017
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICEagle Labs Inc.17dff3c1-3c0b-16f6-e063-6394a90a3c052026-01-21WarningsExact identifier
application number: M017
Pain ReliefANALGESICFullstack Fulfillment2a433cee-8b6f-c280-e063-6394a90ae25a2026-01-21Exact identifier
application number: M017
Walgreens Anti Itch CreamANTI ITCH CREAMWalgreens Companyb545553a-283a-48af-adc5-763758a9ff242026-01-21WarningsExact identifier
application number: M017
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus MentholLIDOCAINE HCL, MENTHOLCVS Pharmacy8aaffa3f-f82f-470c-902d-f366f1a663052026-01-21WarningsExact identifier
application number: M017
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61577-3100-161577310001226.7 g in 1 JUG (61577-3100-1) 226.7 g2026-04-10NoNoCurrent