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 105 mg/mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 59316-833
Product ID 59316-833_3dd73c41-b278-c838-e063-6394a90ab1ed
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59316833
Hyphenated Format 59316-833

Supplemental Identifiers

RxCUI
1489073 1489074
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
  • 105 mg/mL
source: ndc
Packaging
  • 89 mL in 1 BOTTLE (59316-833-10)
  • 118 mL in 1 BOTTLE (59316-833-20)
source: ndc

Packages (2)

59316-833-10 89 mL in 1 BOTTLE (59316-833-10) 59316-833-20 118 mL in 1 BOTTLE (59316-833-20)

Ingredients (1)

menthol (105 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": "3dd73c41-b278-c838-e063-6394a90ab1ed", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["1489073", "1489074"], "spl_set_id": ["00bb462a-27d0-6f74-e063-6394a90a90ec"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "89 mL in 1 BOTTLE (59316-833-10)", "package_ndc": "59316-833-10", "marketing_start_date": "20231201"}, {"sample": false, "description": "118 mL in 1 BOTTLE (59316-833-20)", "package_ndc": "59316-833-20", "marketing_start_date": "20260101"}], "brand_name": "Biofreeze", "product_id": "59316-833_3dd73c41-b278-c838-e063-6394a90ab1ed", "dosage_form": "SPRAY", "product_ndc": "59316-833", "generic_name": "MENTHOL", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Biofreeze", "active_ingredients": [{"name": "MENTHOL", "strength": "105 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}