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 SPRAY
Routes
TOPICAL
Active Ingredients

menthol, unspecified form 100 mg/mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-104
Product ID 59316-104_390a4d8d-b482-0d9a-e063-6394a90a9b53
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2010-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59316104
Hyphenated Format 59316-104

Supplemental Identifiers

RxCUI
667889 1043232
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
  • 100 mg/mL
source: ndc
Packaging
  • 59 mL in 1 BOTTLE, SPRAY (59316-104-10)
  • 118 mL in 1 BOTTLE, SPRAY (59316-104-20)
  • 473 mL in 1 BOTTLE, SPRAY (59316-104-30)
source: ndc

Packages (3)

59316-104-10 59 mL in 1 BOTTLE, SPRAY (59316-104-10) 59316-104-20 118 mL in 1 BOTTLE, SPRAY (59316-104-20) 59316-104-30 473 mL in 1 BOTTLE, SPRAY (59316-104-30)

Ingredients (1)

menthol, unspecified form (100 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": "390a4d8d-b482-0d9a-e063-6394a90a9b53", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["667889", "1043232"], "spl_set_id": ["5edddb99-6596-4a3b-b361-1cc04d032c31"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 BOTTLE, SPRAY (59316-104-10)", "package_ndc": "59316-104-10", "marketing_start_date": "20160825"}, {"sample": false, "description": "118 mL in 1 BOTTLE, SPRAY (59316-104-20)", "package_ndc": "59316-104-20", "marketing_start_date": "20160825"}, {"sample": false, "description": "473 mL in 1 BOTTLE, SPRAY (59316-104-30)", "package_ndc": "59316-104-30", "marketing_start_date": "20160825"}], "brand_name": "Biofreeze", "product_id": "59316-104_390a4d8d-b482-0d9a-e063-6394a90a9b53", "dosage_form": "SPRAY", "product_ndc": "59316-104", "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": "100 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20101101", "listing_expiration_date": "20261231"}