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 35 mg/mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-101
Product ID 59316-101_2a4622c1-eef8-28e2-e063-6294a90abbfa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2016-08-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59316101
Hyphenated Format 59316-101

Supplemental Identifiers

RxCUI
808955 1043451
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
  • 35 mg/mL
source: ndc
Packaging
  • 5 mL in 1 PACKET (59316-101-10)
  • 30 mL in 1 BOTTLE (59316-101-11)
  • 59 mL in 1 TUBE (59316-101-12)
  • 59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)
  • 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15)
  • 3 mL in 1 PACKET (59316-101-19)
  • 118 mL in 1 TUBE (59316-101-20)
  • 473 mL in 1 BOTTLE, PUMP (59316-101-30)
  • 946 mL in 1 BOTTLE, PUMP (59316-101-40)
  • 3785 mL in 1 BOTTLE, PUMP (59316-101-50)
source: ndc

Packages (10)

59316-101-10 5 mL in 1 PACKET (59316-101-10) 59316-101-11 30 mL in 1 BOTTLE (59316-101-11) 59316-101-12 59 mL in 1 TUBE (59316-101-12) 59316-101-13 59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13) 59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15) 59316-101-19 3 mL in 1 PACKET (59316-101-19) 59316-101-20 118 mL in 1 TUBE (59316-101-20) 59316-101-30 473 mL in 1 BOTTLE, PUMP (59316-101-30) 59316-101-40 946 mL in 1 BOTTLE, PUMP (59316-101-40) 59316-101-50 3785 mL in 1 BOTTLE, PUMP (59316-101-50)

Ingredients (1)

menthol, unspecified form (35 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": "2a4622c1-eef8-28e2-e063-6294a90abbfa", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["808955", "1043451"], "spl_set_id": ["684faf63-5e44-4471-8384-e8fa7c0d842a"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 PACKET (59316-101-10)", "package_ndc": "59316-101-10", "marketing_start_date": "20160825"}, {"sample": false, "description": "30 mL in 1 BOTTLE (59316-101-11)", "package_ndc": "59316-101-11", "marketing_start_date": "20160825"}, {"sample": false, "description": "59 mL in 1 TUBE (59316-101-12)", "package_ndc": "59316-101-12", "marketing_start_date": "20160825"}, {"sample": false, "description": "59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)", "package_ndc": "59316-101-13", "marketing_start_date": "20160825"}, {"sample": false, "description": "89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15)", "package_ndc": "59316-101-15", "marketing_start_date": "20160825"}, {"sample": false, "description": "3 mL in 1 PACKET (59316-101-19)", "package_ndc": "59316-101-19", "marketing_start_date": "20220101"}, {"sample": false, "description": "118 mL in 1 TUBE (59316-101-20)", "package_ndc": "59316-101-20", "marketing_start_date": "20160825"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PUMP (59316-101-30)", "package_ndc": "59316-101-30", "marketing_start_date": "20160825"}, {"sample": false, "description": "946 mL in 1 BOTTLE, PUMP (59316-101-40)", "package_ndc": "59316-101-40", "marketing_start_date": "20160825"}, {"sample": false, "description": "3785 mL in 1 BOTTLE, PUMP (59316-101-50)", "package_ndc": "59316-101-50", "marketing_start_date": "20160825"}], "brand_name": "Biofreeze", "product_id": "59316-101_2a4622c1-eef8-28e2-e063-6294a90abbfa", "dosage_form": "GEL", "product_ndc": "59316-101", "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": "35 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160825", "listing_expiration_date": "20261231"}