biofreeze roll-on

Generic: menthol

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

Drug Facts

Product Profile

Brand Name biofreeze roll-on
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 59316-205
Product ID 59316-205_390a5e96-5b04-5949-e063-6294a90a6749
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2013-01-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59316205
Hyphenated Format 59316-205

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 roll-on (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
  • 37 mL in 1 BOTTLE (59316-205-09)
  • 89 mL in 1 BOTTLE (59316-205-10)
  • 74 mL in 1 BOTTLE (59316-205-14)
  • 2 BOTTLE in 1 CARTON (59316-205-81) / 89 mL in 1 BOTTLE (59316-205-10)
  • 2 BOTTLE in 1 CARTON (59316-205-82) / 89 mL in 1 BOTTLE (59316-205-10)
source: ndc

Packages (5)

59316-205-09 37 mL in 1 BOTTLE (59316-205-09) 59316-205-10 89 mL in 1 BOTTLE (59316-205-10) 59316-205-14 74 mL in 1 BOTTLE (59316-205-14) 59316-205-81 2 BOTTLE in 1 CARTON (59316-205-81) / 89 mL in 1 BOTTLE (59316-205-10) 59316-205-82 2 BOTTLE in 1 CARTON (59316-205-82) / 89 mL in 1 BOTTLE (59316-205-10)

Ingredients (1)

menthol, unspecified form (40 mg/mL)

Linked Drug Pages (1)

Biofreeze Roll-On ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "390a5e96-5b04-5949-e063-6294a90a6749", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["415974", "1111683"], "spl_set_id": ["ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "37 mL in 1 BOTTLE (59316-205-09)", "package_ndc": "59316-205-09", "marketing_start_date": "20240315"}, {"sample": false, "description": "89 mL in 1 BOTTLE (59316-205-10)", "package_ndc": "59316-205-10", "marketing_start_date": "20130117"}, {"sample": false, "description": "74 mL in 1 BOTTLE (59316-205-14)", "package_ndc": "59316-205-14", "marketing_start_date": "20130117"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (59316-205-81)  / 89 mL in 1 BOTTLE (59316-205-10)", "package_ndc": "59316-205-81", "marketing_start_date": "20220222"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (59316-205-82)  / 89 mL in 1 BOTTLE (59316-205-10)", "package_ndc": "59316-205-82", "marketing_start_date": "20240325"}], "brand_name": "Biofreeze Roll-On", "product_id": "59316-205_390a5e96-5b04-5949-e063-6294a90a6749", "dosage_form": "GEL", "product_ndc": "59316-205", "generic_name": "MENTHOL", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Biofreeze Roll-On", "active_ingredients": [{"name": "MENTHOL, UNSPECIFIED FORM", "strength": "40 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130117", "listing_expiration_date": "20261231"}