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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5TJD82A1ETCAMPHOR (SYNTHETIC)76-22-2CAMPHOR (SYNTHETIC)

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61577-3100-161577310001226.7 g in 1 JUG (61577-3100-1) 226.7 g2026-04-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Santa Calma Plus Warming Pain ReliefSOMBRA COSMETICS INC.2026-04-24HUMAN OTC DRUG LABEL16