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: 684faf63-5e44-4471-8384-e8fa7c0d842a
SPL ID: 51b434c9-228b-2c05-e063-6394a90a1e94
Version: 43
Effective date: 2026-05-13
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:55:57

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 · 34 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	59316-101-25	openfda.package_ndc
ndc	package	59316-101-11	openfda.package_ndc
ndc	package	59316-101-10	openfda.package_ndc
ndc	package	59316-101-20	openfda.package_ndc
ndc	package	59316-101-13	openfda.package_ndc
ndc	package	59316-101-19	openfda.package_ndc
ndc	package	59316-101-12	openfda.package_ndc
ndc	package	59316-101-30	openfda.package_ndc
ndc	package	59316-101-40	openfda.package_ndc
ndc	package	59316-101-15	openfda.package_ndc
ndc	package	59316-101-21	openfda.package_ndc
ndc	package	59316-101-50	openfda.package_ndc
ndc	product	59316-101	openfda.product_ndc
ndc11	package	59316010112	derived:openfda.package_ndc
ndc11	package	59316010130	derived:openfda.package_ndc
ndc11	package	59316010120	derived:openfda.package_ndc
ndc11	package	59316010113	derived:openfda.package_ndc
ndc11	package	59316010121	derived:openfda.package_ndc
ndc11	package	59316010115	derived:openfda.package_ndc
ndc11	package	59316010119	derived:openfda.package_ndc
ndc11	package	59316010111	derived:openfda.package_ndc
ndc11	package	59316010150	derived:openfda.package_ndc
ndc11	package	59316010110	derived:openfda.package_ndc
ndc11	package	59316010140	derived:openfda.package_ndc
ndc11	package	59316010125	derived:openfda.package_ndc
rxcui		808955	openfda.rxcui
rxcui		1043451	openfda.rxcui
spl id		51b434c9-228b-2c05-e063-6394a90a1e94	id
spl set id		684faf63-5e44-4471-8384-e8fa7c0d842a	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 damaged 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 recur. If pregnant or breastfeeding: Ask a health professional before use. Keep out of the 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.