Biofreeze

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Biofreeze
Generic name: MENTHOL
Manufacturer: Reckitt Benckiser LLC
Product type: HUMAN OTC DRUG
SPL set ID: 5edddb99-6596-4a3b-b361-1cc04d032c31
SPL ID: 51b427be-af9f-1fbe-e063-6394a90acada
Version: 40
Effective date: 2026-05-13
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:14

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Biofreeze	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Reckitt Benckiser LLC	openfda.manufacturer_name
ndc	package	59316-104-25	openfda.package_ndc
ndc	package	59316-104-20	openfda.package_ndc
ndc	package	59316-104-30	openfda.package_ndc
ndc	package	59316-104-10	openfda.package_ndc
ndc	product	59316-104	openfda.product_ndc
ndc11	package	59316010410	derived:openfda.package_ndc
ndc11	package	59316010420	derived:openfda.package_ndc
ndc11	package	59316010430	derived:openfda.package_ndc
ndc11	package	59316010425	derived:openfda.package_ndc
rxcui		1043232	openfda.rxcui
rxcui		667889	openfda.rxcui
spl id		51b427be-af9f-1fbe-e063-6394a90acada	id
spl set id		5edddb99-6596-4a3b-b361-1cc04d032c31	set_id
unii		L7T10EIP3A	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: For external use only Flammable: Keep away from excessive heat or open flame Ask a doctor before use if you have: sensitive skin When Using This Product: -Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages skin -Do not use with other ointments, creams, sprays or liniments -Do not apply to irritated skin or if excessive irritation develops -Do not bandage - Wash hands after use with cool water -Do not use with heating pad or device Stop Use And Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur If pregnant or breastfeeding: Ask a health professional before use. Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.