FDA.reportPublic FDA data

menthol 105 MG/ML Topical Spray [Biofreeze]

RxCUI
1489074
RxNorm name
menthol 105 MG/ML Topical Spray [Biofreeze]
Display name
BIOFREEZE (Topical)
Full name
menthol 105 MG/ML Topical Spray [Biofreeze]
Term type
SBD
Status
Active
Strength
10.5%
Dose form
Spray
Route
Topical
Updated
2026-08-18 06:18:27

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032014
Active start
032014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
menthol105 MG / 1 MLmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Spray346165

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
menthol6750

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRBiofreeze 10.5 % Topical Spray1NAMES
RxNorm Namementhol 105 MG/ML Topical Spray [Biofreeze]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI14890741CODES
MMSL_CODEBD336221CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59316-114-1059316-114Biofreeze MENTHOLReckitt Benckiser LLCM017
59316-114-2559316-114Biofreeze MENTHOLReckitt Benckiser LLCM017
59316-114-3059316-114Biofreeze MENTHOLReckitt Benckiser LLCM017
59316-120-2059316-120Biofreeze Professional MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCM017
59316-120-3059316-120Biofreeze Professional MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCM017
59316-833-1059316-833Biofreeze MENTHOLReckitt Benckiser LLCM017
59316-833-2059316-833Biofreeze MENTHOLReckitt Benckiser LLCM017
59316-834-2059316-834Biofreeze Professional MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCM017
59316-834-2259316-834Biofreeze Professional MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01759316-114Biofreeze MENTHOLOTC MONOGRAPH DRUGReckitt Benckiser LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11SourceActive
31124000007rxnav_ndcsyes
59316011410rxnav_ndcsyes
59316011425rxnav_ndcsyes
59316011430rxnav_ndcsyes
59316012020rxnav_ndcsyes
59316012030rxnav_ndcsyes
59316083310rxnav_ndcsyes
59316083320rxnav_ndcsyes
59316083420rxnav_ndcsyes
59316083422rxnav_ndcsyes
59316011450rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
ndc (package): 59316-834-22
ndc (package): 59316-834-20
ndc (product): 59316-834
ndc11 (package): 59316083422
ndc11 (package): 59316083420
rxcui: 1489074
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
ndc (package): 59316-120-30
ndc (package): 59316-120-20
ndc (product): 59316-120
ndc11 (package): 59316012030
ndc11 (package): 59316012020
rxcui: 1489074
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
ndc (package): 59316-114-10
ndc (package): 59316-114-25
ndc (package): 59316-114-30
ndc (product): 59316-114
ndc11 (package): 59316011450
ndc11 (package): 59316011425
ndc11 (package): 59316011410
ndc11 (package): 59316011430
rxcui: 1489074
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
ndc (package): 59316-833-10
ndc (package): 59316-833-20
ndc (product): 59316-833
ndc11 (package): 59316083310
ndc11 (package): 59316083320
rxcui: 1489074

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4c798b06-6ee5-41d1-8a14-f6889512ade3BIOFREEZE 10.5 % Topical Spray [PSN] · menthol 105 MG/ML Topical Spray [Biofreeze] [SBD] · Biofreeze 10.5 % Topical Spray [SY] · Biofreeze 105 MG/ML Topical Spray [SY]421Biofreeze20260513
00bba5d2-b0e0-701c-e063-6294a90a5741BIOFREEZE 10.5 % Topical Spray [PSN] · menthol 105 MG/ML Topical Spray [Biofreeze] [SBD] · Biofreeze 10.5 % Topical Spray [SY] · Biofreeze 105 MG/ML Topical Spray [SY]415Biofreeze ® Professional Spray20260515
db982baf-31ea-4f09-90e3-cd5facb5dfe5BIOFREEZE 10.5 % Topical Spray [PSN] · menthol 105 MG/ML Topical Spray [Biofreeze] [SBD] · Biofreeze 10.5 % Topical Spray [SY] · Biofreeze 105 MG/ML Topical Spray [SY]412Biofreeze ® Professional Spray20260515
00bb462a-27d0-6f74-e063-6394a90a90ecBIOFREEZE 10.5 % Topical Spray [PSN] · menthol 105 MG/ML Topical Spray [Biofreeze] [SBD] · Biofreeze 10.5 % Topical Spray [SY] · Biofreeze 105 MG/ML Topical Spray [SY]412Biofreeze Spray20260513

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
00bba5d2-b0e0-701c-e063-6294a90a5741Biofreeze ® Professional SprayReckitt Benckiser LLC20260515
db982baf-31ea-4f09-90e3-cd5facb5dfe5Biofreeze ® Professional SprayReckitt Benckiser LLC20260515
4c798b06-6ee5-41d1-8a14-f6889512ade3BiofreezeReckitt Benckiser LLC20260513
00bb462a-27d0-6f74-e063-6394a90a90ecBiofreeze SprayReckitt Benckiser LLC20260513
bceb0d38-bb4f-4048-bfea-06a508e06255Biofreeze SprayPerformance Health LLC20190618

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD004342Drug HypersensitivityDISEASEci_withmenthol
MEDRTD010146PainDISEASEmay_treatmenthol
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH105 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymBIOFREEZE 10.5 % Topical Spray
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon