SOMBRA COOL THERAPY

Generic: MENTHOL

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

Drug Facts

Product Profile

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

MENTHOL .06 g/g

Identifiers & Regulatory

Product NDC 61577-3221
Product ID 61577-3221_3622f4c4-6539-7ad2-e063-6294a90a3cee
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2016-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 615773221
Hyphenated Format 61577-3221

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 COOL THERAPY (source: ndc)
Generic Name MENTHOL (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .06 g/g
source: ndc
Packaging
  • 3628.7 g in 1 BOTTLE, PUMP (61577-3221-1)
  • 907.2 g in 1 BOTTLE, PUMP (61577-3221-2)
  • 226.8 g in 1 JAR (61577-3221-3)
  • 113.4 g in 1 JAR (61577-3221-4)
  • 85 g in 1 BOTTLE, PLASTIC (61577-3221-5)
  • 113.4 g in 1 TUBE (61577-3221-6)
  • 56.7 g in 1 JAR (61577-3221-7)
  • 5 g in 1 POUCH (61577-3221-9)
source: ndc

Packages (8)

61577-3221-1 3628.7 g in 1 BOTTLE, PUMP (61577-3221-1) 61577-3221-2 907.2 g in 1 BOTTLE, PUMP (61577-3221-2) 61577-3221-3 226.8 g in 1 JAR (61577-3221-3) 61577-3221-4 113.4 g in 1 JAR (61577-3221-4) 61577-3221-5 85 g in 1 BOTTLE, PLASTIC (61577-3221-5) 61577-3221-6 113.4 g in 1 TUBE (61577-3221-6) 61577-3221-7 56.7 g in 1 JAR (61577-3221-7) 61577-3221-9 5 g in 1 POUCH (61577-3221-9)

Ingredients (1)

MENTHOL (.06 g/g)

Linked Drug Pages (1)

SOMBRA COOL THERAPY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3622f4c4-6539-7ad2-e063-6294a90a3cee", "openfda": {"upc": ["0763669140035"], "unii": ["L7T10EIP3A"], "rxcui": ["415976"], "spl_set_id": ["87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3"], "manufacturer_name": ["SOMBRA COSMETICS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3628.7 g in 1 BOTTLE, PUMP (61577-3221-1)", "package_ndc": "61577-3221-1", "marketing_start_date": "20160521"}, {"sample": false, "description": "907.2 g in 1 BOTTLE, PUMP (61577-3221-2)", "package_ndc": "61577-3221-2", "marketing_start_date": "20160521"}, {"sample": false, "description": "226.8 g in 1 JAR (61577-3221-3)", "package_ndc": "61577-3221-3", "marketing_start_date": "20160521"}, {"sample": false, "description": "113.4 g in 1 JAR (61577-3221-4)", "package_ndc": "61577-3221-4", "marketing_start_date": "20160521"}, {"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (61577-3221-5)", "package_ndc": "61577-3221-5", "marketing_start_date": "20160521"}, {"sample": false, "description": "113.4 g in 1 TUBE (61577-3221-6)", "package_ndc": "61577-3221-6", "marketing_start_date": "20160521"}, {"sample": false, "description": "56.7 g in 1 JAR (61577-3221-7)", "package_ndc": "61577-3221-7", "marketing_start_date": "20160521"}, {"sample": false, "description": "5 g in 1 POUCH (61577-3221-9)", "package_ndc": "61577-3221-9", "marketing_start_date": "20160521"}], "brand_name": "SOMBRA COOL THERAPY", "product_id": "61577-3221_3622f4c4-6539-7ad2-e063-6294a90a3cee", "dosage_form": "GEL", "product_ndc": "61577-3221", "generic_name": "MENTHOL", "labeler_name": "SOMBRA COSMETICS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SOMBRA COOL THERAPY", "active_ingredients": [{"name": "MENTHOL", "strength": ".06 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160429", "listing_expiration_date": "20261231"}