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, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBiofreeze 3.5 % Topical GelNAMES
RxNorm Namementhol 0.035 MG/MG Topical Gel [Biofreeze]NAMES
RxNorm SynonymBiofreeze 0.035 MG/MG Topical GelNAMES
RxNorm SynonymBiofreeze 3.5 % Topical GelNAMES
TTYSBDATTRIBUTES
SPL_SET_ID684faf63-5e44-4471-8384-e8fa7c0d842aCODES
RxCUI1043451CODES
MMSL_CODEBD30294CODES

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#

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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
684faf63-5e44-4471-8384-e8fa7c0d842amenthol 0.035 MG/MG Topical Gel [Biofreeze]SBD43Biofreeze Pain Relieving Gel20260513
684faf63-5e44-4471-8384-e8fa7c0d842aBIOFREEZE 3.5 % Topical GelPSN43Biofreeze Pain Relieving Gel20260513
684faf63-5e44-4471-8384-e8fa7c0d842aBiofreeze 0.035 MG/MG Topical GelSY43Biofreeze Pain Relieving Gel20260513
684faf63-5e44-4471-8384-e8fa7c0d842aBiofreeze 3.5 % Topical GelSY43Biofreeze Pain Relieving Gel20260513

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
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD30294
CODESRxCUI1043451
CODESSPL_SET_ID684faf63-5e44-4471-8384-e8fa7c0d842a
NAMESPrescribable SynonymBIOFREEZE 3.5 % Topical Gel
NAMESRXNAV_STRBiofreeze 3.5 % Topical Gel
NAMESRxNorm Namementhol 0.035 MG/MG Topical Gel [Biofreeze]
NAMESRxNorm SynonymBiofreeze 0.035 MG/MG Topical Gel
NAMESRxNorm SynonymBiofreeze 3.5 % Topical Gel
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon