SOMBRA WARM THERAPY

Generic: MENTHOL CAMPHOR

Labeler: SOMBRA COSMETICS INC.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Active

Drug Facts

Product Profile

Brand Name SOMBRA WARM THERAPY
Generic Name MENTHOL CAMPHOR
Labeler SOMBRA COSMETICS INC.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

CAMPHOR (SYNTHETIC) .03 g/g, MENTHOL .03 g/g

Identifiers & Regulatory

Product NDC 61577-3216
Product ID 61577-3216_362255b1-37f7-6ee0-e063-6394a90a98ee
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2016-06-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 615773216
Hyphenated Format 61577-3216

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name SOMBRA WARM THERAPY (source: ndc)
Generic Name MENTHOL CAMPHOR (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .03 g/g
source: ndc
Packaging
  • 3628.7 g in 1 BOTTLE, PUMP (61577-3216-1)
  • 907.2 g in 1 BOTTLE, PUMP (61577-3216-2)
  • 226.8 g in 1 JAR (61577-3216-3)
  • 113.4 g in 1 JAR (61577-3216-4)
  • 85 g in 1 BOTTLE, PLASTIC (61577-3216-5)
  • 113.4 g in 1 TUBE (61577-3216-6)
  • 56.7 g in 1 JAR (61577-3216-7)
  • 5 g in 1 POUCH (61577-3216-9)
source: ndc

Packages (8)

61577-3216-1 3628.7 g in 1 BOTTLE, PUMP (61577-3216-1) 61577-3216-2 907.2 g in 1 BOTTLE, PUMP (61577-3216-2) 61577-3216-3 226.8 g in 1 JAR (61577-3216-3) 61577-3216-4 113.4 g in 1 JAR (61577-3216-4) 61577-3216-5 85 g in 1 BOTTLE, PLASTIC (61577-3216-5) 61577-3216-6 113.4 g in 1 TUBE (61577-3216-6) 61577-3216-7 56.7 g in 1 JAR (61577-3216-7) 61577-3216-9 5 g in 1 POUCH (61577-3216-9)

Ingredients (2)

CAMPHOR (SYNTHETIC) (.03 g/g) MENTHOL (.03 g/g)

Linked Drug Pages (1)

SOMBRA WARM THERAPY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "362255b1-37f7-6ee0-e063-6394a90a98ee", "openfda": {"upc": ["0763669000728"], "unii": ["5TJD82A1ET", "L7T10EIP3A"], "rxcui": ["630714", "1090954"], "spl_set_id": ["de78dba9-53b3-4dbd-9dd2-6a692378da34"], "manufacturer_name": ["SOMBRA COSMETICS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3628.7 g in 1 BOTTLE, PUMP (61577-3216-1)", "package_ndc": "61577-3216-1", "marketing_start_date": "20160614"}, {"sample": false, "description": "907.2 g in 1 BOTTLE, PUMP (61577-3216-2)", "package_ndc": "61577-3216-2", "marketing_start_date": "20160614"}, {"sample": false, "description": "226.8 g in 1 JAR (61577-3216-3)", "package_ndc": "61577-3216-3", "marketing_start_date": "20160614"}, {"sample": false, "description": "113.4 g in 1 JAR (61577-3216-4)", "package_ndc": "61577-3216-4", "marketing_start_date": "20160614"}, {"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (61577-3216-5)", "package_ndc": "61577-3216-5", "marketing_start_date": "20160614"}, {"sample": false, "description": "113.4 g in 1 TUBE (61577-3216-6)", "package_ndc": "61577-3216-6", "marketing_start_date": "20160614"}, {"sample": false, "description": "56.7 g in 1 JAR (61577-3216-7)", "package_ndc": "61577-3216-7", "marketing_start_date": "20160614"}, {"sample": false, "description": "5 g in 1 POUCH (61577-3216-9)", "package_ndc": "61577-3216-9", "marketing_start_date": "20160614"}], "brand_name": "SOMBRA WARM THERAPY", "product_id": "61577-3216_362255b1-37f7-6ee0-e063-6394a90a98ee", "dosage_form": "GEL", "product_ndc": "61577-3216", "generic_name": "MENTHOL CAMPHOR", "labeler_name": "SOMBRA COSMETICS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SOMBRA WARM THERAPY", "active_ingredients": [{"name": "CAMPHOR (SYNTHETIC)", "strength": ".03 g/g"}, {"name": "MENTHOL", "strength": ".03 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160613", "listing_expiration_date": "20261231"}