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
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.03; .03 g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A

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

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