FDA.reportPublic FDA data

menthol 0.035 MG/MG Topical Gel [Biofreeze]

RxCUI
1043451
RxNorm name
menthol 0.035 MG/MG Topical Gel [Biofreeze]
Display name
BIOFREEZE (Topical)
Full name
menthol 0.035 MG/MG Topical Gel [Biofreeze]
Term type
SBD
Status
Active
Strength
3.5%
Dose form
Gel
Route
Topical
Updated
2026-07-15 00:10:48

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
menthol0.035 MG / 1 MGmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
menthol6750

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRBiofreeze 3.5 % Topical Gel1NAMES
RxNorm Namementhol 0.035 MG/MG Topical Gel [Biofreeze]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID684faf63-5e44-4471-8384-e8fa7c0d842a1CODES
RxCUI10434511CODES
MMSL_CODEBD302941CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59316-101-1059316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-1159316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-1259316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-1359316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-1559316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-1959316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-2059316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-3059316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-4059316-101Biofreeze MentholReckitt Benckiser LLCM017
59316-101-5059316-101Biofreeze MentholReckitt Benckiser LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01759316-101Biofreeze MentholOTC MONOGRAPH DRUGReckitt Benckiser LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 18 matching rows.

NDC11, Source, Active table
NDC11SourceActive
59316010110rxnav_ndcsyes
59316010111rxnav_ndcsyes
59316010112rxnav_ndcsyes
59316010113rxnav_ndcsyes
59316010115rxnav_ndcsyes
59316010119rxnav_ndcsyes
59316010120rxnav_ndcsyes
59316010125rxnav_ndcsyes
59316010130rxnav_ndcsyes
59316010140rxnav_ndcsyes
59316010150rxnav_ndcsyes
23490784000rxnav_historical
52959069703rxnav_historical
52959069704rxnav_historical
55045980002rxnav_historical
59316010121rxnav_historical
59316020112rxnav_historical
59316020117rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
ndc (package): 59316-101-11
ndc (package): 59316-101-10
ndc (package): 59316-101-20
ndc (package): 59316-101-13
ndc (package): 59316-101-19
ndc (package): 59316-101-12
ndc (package): 59316-101-30
ndc (package): 59316-101-40
ndc (package): 59316-101-15
ndc (package): 59316-101-50
ndc (product): 59316-101
ndc11 (package): 59316010112
ndc11 (package): 59316010130
ndc11 (package): 59316010120
ndc11 (package): 59316010113
ndc11 (package): 59316010121
ndc11 (package): 59316010115
ndc11 (package): 59316010119
ndc11 (package): 59316010111
ndc11 (package): 59316010150
ndc11 (package): 59316010110
ndc11 (package): 59316010140
ndc11 (package): 59316010125
rxcui: 1043451

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
684faf63-5e44-4471-8384-e8fa7c0d842aBIOFREEZE 3.5 % Topical Gel [PSN] · menthol 0.035 MG/MG Topical Gel [Biofreeze] [SBD] · Biofreeze 0.035 MG/MG Topical Gel [SY] · Biofreeze 3.5 % Topical Gel [SY]443Biofreeze Pain Relieving Gel20260513

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
684faf63-5e44-4471-8384-e8fa7c0d842aBiofreeze Pain Relieving GelReckitt Benckiser LLC | Span Packaging Services dba Multi-Pack Solutions20260513

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_STRENGTH0.035 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymBIOFREEZE 3.5 % Topical Gel
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon