biofreeze

Generic: menthol

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name biofreeze
Generic Name menthol
Labeler rb health (us) llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

menthol, unspecified form 40 mg/mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-102
Product ID 59316-102_0a0e1685-b635-7e21-e063-6394a90a5324
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2012-01-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59316102
Hyphenated Format 59316-102

Supplemental Identifiers

RxCUI
415974 1111683
UNII
L7T10EIP3A

Packaging Origin

Original Packager
true

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 biofreeze (source: ndc)
Generic Name menthol (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (59316-102-10)
  • 3 mL in 1 BOTTLE (59316-102-11)
  • 89 mL in 1 BOTTLE (59316-102-12)
  • 118 mL in 1 BOTTLE (59316-102-20)
  • 237 mL in 1 BOTTLE (59316-102-28)
  • 473 mL in 1 BOTTLE (59316-102-30)
  • 946 mL in 1 BOTTLE (59316-102-40)
  • 3785 mL in 1 CONTAINER (59316-102-50)
  • 44 mL in 1 TUBE (59316-102-80)
  • 100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10)
  • 30 mL in 1 BOTTLE (59316-102-98)
source: ndc

Packages (11)

59316-102-10 5 mL in 1 BOTTLE (59316-102-10) 59316-102-11 3 mL in 1 BOTTLE (59316-102-11) 59316-102-12 89 mL in 1 BOTTLE (59316-102-12) 59316-102-20 118 mL in 1 BOTTLE (59316-102-20) 59316-102-28 237 mL in 1 BOTTLE (59316-102-28) 59316-102-30 473 mL in 1 BOTTLE (59316-102-30) 59316-102-40 946 mL in 1 BOTTLE (59316-102-40) 59316-102-50 3785 mL in 1 CONTAINER (59316-102-50) 59316-102-80 44 mL in 1 TUBE (59316-102-80) 59316-102-90 100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10) 59316-102-98 30 mL in 1 BOTTLE (59316-102-98)

Ingredients (1)

menthol, unspecified form (40 mg/mL)

Linked Drug Pages (1)

BIOFREEZE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0a0e1685-b635-7e21-e063-6394a90a5324", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["415974", "1111683"], "spl_set_id": ["83d5c2f2-2413-4d28-83b2-0808d0917b4d"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (59316-102-10)", "package_ndc": "59316-102-10", "marketing_start_date": "20120103"}, {"sample": false, "description": "3 mL in 1 BOTTLE (59316-102-11)", "package_ndc": "59316-102-11", "marketing_start_date": "20120103"}, {"sample": false, "description": "89 mL in 1 BOTTLE (59316-102-12)", "package_ndc": "59316-102-12", "marketing_start_date": "20160919"}, {"sample": false, "description": "118 mL in 1 BOTTLE (59316-102-20)", "package_ndc": "59316-102-20", "marketing_start_date": "20120103"}, {"sample": false, "description": "237 mL in 1 BOTTLE (59316-102-28)", "package_ndc": "59316-102-28", "marketing_start_date": "20160919"}, {"sample": false, "description": "473 mL in 1 BOTTLE (59316-102-30)", "package_ndc": "59316-102-30", "marketing_start_date": "20120103"}, {"sample": false, "description": "946 mL in 1 BOTTLE (59316-102-40)", "package_ndc": "59316-102-40", "marketing_start_date": "20120103"}, {"sample": false, "description": "3785 mL in 1 CONTAINER (59316-102-50)", "package_ndc": "59316-102-50", "marketing_start_date": "20120103"}, {"sample": false, "description": "44 mL in 1 TUBE (59316-102-80)", "package_ndc": "59316-102-80", "marketing_start_date": "20181102"}, {"sample": false, "description": "100 BOTTLE in 1 CARTON (59316-102-90)  / 5 mL in 1 BOTTLE (59316-102-10)", "package_ndc": "59316-102-90", "marketing_start_date": "20120103"}, {"sample": false, "description": "30 mL in 1 BOTTLE (59316-102-98)", "package_ndc": "59316-102-98", "marketing_start_date": "20120103"}], "brand_name": "BIOFREEZE", "product_id": "59316-102_0a0e1685-b635-7e21-e063-6394a90a5324", "dosage_form": "GEL", "product_ndc": "59316-102", "generic_name": "MENTHOL", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BIOFREEZE", "active_ingredients": [{"name": "MENTHOL, UNSPECIFIED FORM", "strength": "40 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120103", "listing_expiration_date": "20261231"}