FDA.reportPublic FDA data

menthol 0.04 MG/MG Topical Gel [Biofreeze]

RxCUI
1111683
RxNorm name
menthol 0.04 MG/MG Topical Gel [Biofreeze]
Display name
BIOFREEZE (Topical)
Full name
menthol 0.04 MG/MG Topical Gel [Biofreeze]
Term type
SBD
Status
Active
Strength
4%
Dose form
Gel
Route
Topical
Updated
2026-07-17 21:40:23

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072011
Active start
022012
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
menthol0.04 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 4 % Topical GelNAMES
RxNorm Namementhol 0.04 MG/MG Topical Gel [Biofreeze]NAMES
RxNorm SynonymBiofreeze 0.04 MG/MG Topical GelNAMES
RxNorm SynonymBiofreeze 4 % Topical GelNAMES
TTYSBDATTRIBUTES
SPL_SET_ID4d3dcb8f-2075-6bbc-e063-6394a90a4992CODES
SPL_SET_ID814b37ea-5441-4cec-8794-71ca01d849aeCODES
SPL_SET_ID83d5c2f2-2413-4d28-83b2-0808d0917b4dCODES
SPL_SET_ID939dbbc3-71ec-4990-840e-7c9b8d430562CODES
SPL_SET_IDa8d59d45-0e85-43d1-affd-bbe922c4acb1CODES
SPL_SET_IDcc1cba14-da40-4d7d-b522-b5c648798e96CODES
SPL_SET_IDebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbCODES
SPL_SET_IDf0c4d165-a242-4fb5-b2de-d64a825a29e9CODES
SPL_SET_IDf5c8c08b-c7c0-f84d-e053-2a95a90add15CODES
SPL_SET_IDf67d7b7a-8922-73f6-e053-2995a90a2e80CODES
RxCUI1111683CODES
MMSL_CODEBD12742CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50090-6358-050090-6358Biofreeze Roll-On MENTHOLA-S Medication SolutionsM017
50090-6361-050090-6361Biofreeze Colorless MENTHOLA-S Medication SolutionsM012
59316-102-1059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-1159316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-1259316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-2059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-2859316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-3059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-4059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-5059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-8059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-9059316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-102-9859316-102BIOFREEZE MENTHOLReckitt Benckiser LLCM017
59316-103-1259316-103Biofreeze Colorless MENTHOLReckitt Benckiser LLCM017
59316-103-2059316-103Biofreeze Colorless MENTHOLReckitt Benckiser LLCM017
59316-103-4059316-103Biofreeze Colorless MENTHOLReckitt Benckiser LLCM017
59316-121-1059316-121Biofreeze Overnight Gel MentholReckitt Benckiser LLCM017
59316-205-0959316-205Biofreeze Roll-On MENTHOLReckitt Benckiser LLCM017
59316-205-1059316-205Biofreeze Roll-On MENTHOLReckitt Benckiser LLCM017
59316-205-1459316-205Biofreeze Roll-On MENTHOLReckitt Benckiser LLCM017
59316-205-8159316-205Biofreeze Roll-On MENTHOLReckitt Benckiser LLCM017
59316-205-8259316-205Biofreeze Roll-On MENTHOLReckitt Benckiser LLCM017
59316-206-1059316-206Biofreeze Colorless Roll-On MENTHOLReckitt Benckiser LLCM017
59316-207-1459316-207Biofreeze Overnight Roll-on MentholReckitt Benckiser LLCM017
59316-209-1459316-209Biofreeze Roll-On and Overnight Roll-On MentholReckitt Benckiser LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01750090-6358Biofreeze Roll-On MENTHOLOTC MONOGRAPH DRUGA-S Medication Solutions
M01250090-6361Biofreeze Colorless MENTHOLOTC MONOGRAPH DRUGA-S Medication Solutions

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
31124000003rxnav_ndcsyes
31124000004rxnav_ndcsyes
31124000006rxnav_ndcsyes
50090635800rxnav_ndcsyes
50090636100rxnav_ndcsyes
59316010210rxnav_ndcsyes
59316010211rxnav_ndcsyes
59316010212rxnav_ndcsyes
59316010216rxnav_ndcsyes
59316010220rxnav_ndcsyes
59316010228rxnav_ndcsyes
59316010230rxnav_ndcsyes
59316010240rxnav_ndcsyes
59316010250rxnav_ndcsyes
59316010280rxnav_ndcsyes
59316010290rxnav_ndcsyes
59316010291rxnav_ndcsyes
59316010292rxnav_ndcsyes
59316010298rxnav_ndcsyes
59316010312rxnav_ndcsyes
59316010320rxnav_ndcsyes
59316010340rxnav_ndcsyes
59316012110rxnav_ndcsyes
59316020509rxnav_ndcsyes
59316020510rxnav_ndcsyes
59316020514rxnav_ndcsyes
59316020581rxnav_ndcsyes
59316020582rxnav_ndcsyes
59316020610rxnav_ndcsyes
59316020714rxnav_ndcsyes
59316020914rxnav_ndcsyes
59316010215rxnav_historical
59316010225rxnav_historical
59316010310rxnav_historical
59316010311rxnav_historical
59316010315rxnav_historical
59316010328rxnav_historical
61786079935rxnav_historical
68788645701rxnav_historical
70518006800rxnav_historical
70518048500rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
83d5c2f2-2413-4d28-83b2-0808d0917b4dBIOFREEZE 4 % Topical GelPSN35BiOFREEZE ®20260513
83d5c2f2-2413-4d28-83b2-0808d0917b4dBiofreeze 4 % Topical GelSY35BiOFREEZE ®20260513
83d5c2f2-2413-4d28-83b2-0808d0917b4dBiofreeze 0.04 MG/MG Topical GelSY35BiOFREEZE ®20260513
83d5c2f2-2413-4d28-83b2-0808d0917b4dmenthol 0.04 MG/MG Topical Gel [Biofreeze]SBD35BiOFREEZE ®20260513
939dbbc3-71ec-4990-840e-7c9b8d430562menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD31Biofreeze ® Colorless20260513
939dbbc3-71ec-4990-840e-7c9b8d430562BIOFREEZE 4 % Topical GelPSN31Biofreeze ® Colorless20260513
939dbbc3-71ec-4990-840e-7c9b8d430562Biofreeze 4 % Topical GelSY31Biofreeze ® Colorless20260513
939dbbc3-71ec-4990-840e-7c9b8d430562Biofreeze 0.04 MG/MG Topical GelSY31Biofreeze ® Colorless20260513
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbmenthol 0.04 MG/MG Topical Gel [Biofreeze]SBD21Biofreeze ® Roll-On20260515
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbBIOFREEZE 4 % Topical GelPSN21Biofreeze ® Roll-On20260515
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbBiofreeze 4 % Topical GelSY21Biofreeze ® Roll-On20260515
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbBiofreeze 0.04 MG/MG Topical GelSY21Biofreeze ® Roll-On20260515
a8d59d45-0e85-43d1-affd-bbe922c4acb1Biofreeze 4 % Topical GelSY10Biofreeze Colorless Roll-On20260513
a8d59d45-0e85-43d1-affd-bbe922c4acb1menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD10Biofreeze Colorless Roll-On20260513
a8d59d45-0e85-43d1-affd-bbe922c4acb1BIOFREEZE 4 % Topical GelPSN10Biofreeze Colorless Roll-On20260513
a8d59d45-0e85-43d1-affd-bbe922c4acb1Biofreeze 0.04 MG/MG Topical GelSY10Biofreeze Colorless Roll-On20260513
4d3dcb8f-2075-6bbc-e063-6394a90a4992Biofreeze 0.04 MG/MG Topical GelSY5BioFreeze Day & Overnight Roll-On20260515
4d3dcb8f-2075-6bbc-e063-6394a90a4992menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD5BioFreeze Day & Overnight Roll-On20260515
4d3dcb8f-2075-6bbc-e063-6394a90a4992BIOFREEZE 4 % Topical GelPSN5BioFreeze Day & Overnight Roll-On20260515
4d3dcb8f-2075-6bbc-e063-6394a90a4992Biofreeze 4 % Topical GelSY5BioFreeze Day & Overnight Roll-On20260515
cc1cba14-da40-4d7d-b522-b5c648798e96Biofreeze 0.04 MG/MG Topical GelSY4Biofreeze ® Colorless20241111
cc1cba14-da40-4d7d-b522-b5c648798e96Biofreeze 4 % Topical GelSY4Biofreeze ® Colorless20241111
cc1cba14-da40-4d7d-b522-b5c648798e96menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD4Biofreeze ® Colorless20241111
cc1cba14-da40-4d7d-b522-b5c648798e96BIOFREEZE 4 % Topical GelPSN4Biofreeze ® Colorless20241111
f5c8c08b-c7c0-f84d-e053-2a95a90add15Biofreeze 4 % Topical GelSY3Biofreeze Overnight Gel20260515
f5c8c08b-c7c0-f84d-e053-2a95a90add15BIOFREEZE 4 % Topical GelPSN3Biofreeze Overnight Gel20260515
f5c8c08b-c7c0-f84d-e053-2a95a90add15Biofreeze 0.04 MG/MG Topical GelSY3Biofreeze Overnight Gel20260515
f5c8c08b-c7c0-f84d-e053-2a95a90add15menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD3Biofreeze Overnight Gel20260515
f67d7b7a-8922-73f6-e053-2995a90a2e80Biofreeze 0.04 MG/MG Topical GelSY3BiOFREEZE ® Overnight Roll-on20260515
f67d7b7a-8922-73f6-e053-2995a90a2e80BIOFREEZE 4 % Topical GelPSN3BiOFREEZE ® Overnight Roll-on20260515
f67d7b7a-8922-73f6-e053-2995a90a2e80menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD3BiOFREEZE ® Overnight Roll-on20260515
f67d7b7a-8922-73f6-e053-2995a90a2e80Biofreeze 4 % Topical GelSY3BiOFREEZE ® Overnight Roll-on20260515
814b37ea-5441-4cec-8794-71ca01d849aementhol 0.04 MG/MG Topical Gel [Biofreeze]SBD3Biofreeze ® Roll-On20231030
814b37ea-5441-4cec-8794-71ca01d849aeBiofreeze 0.04 MG/MG Topical GelSY3Biofreeze ® Roll-On20231030
814b37ea-5441-4cec-8794-71ca01d849aeBIOFREEZE 4 % Topical GelPSN3Biofreeze ® Roll-On20231030
814b37ea-5441-4cec-8794-71ca01d849aeBiofreeze 4 % Topical GelSY3Biofreeze ® Roll-On20231030
f0c4d165-a242-4fb5-b2de-d64a825a29e9menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD1Biofreeze Gel20181107
f0c4d165-a242-4fb5-b2de-d64a825a29e9Biofreeze 0.04 MG/MG Topical GelSY1Biofreeze Gel20181107
f0c4d165-a242-4fb5-b2de-d64a825a29e9BIOFREEZE 4 % Topical GelPSN1Biofreeze Gel20181107
f0c4d165-a242-4fb5-b2de-d64a825a29e9Biofreeze 4 % Topical GelSY1Biofreeze Gel20181107

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbBiofreeze ® Roll-OnReckitt Benckiser LLC20260515
4d3dcb8f-2075-6bbc-e063-6394a90a4992BioFreeze Day & Overnight Roll-OnReckitt Benckiser LLC20260515
f5c8c08b-c7c0-f84d-e053-2a95a90add15Biofreeze Overnight GelReckitt Benckiser LLC20260515
f67d7b7a-8922-73f6-e053-2995a90a2e80BiOFREEZE ® Overnight Roll-onReckitt Benckiser LLC20260515
83d5c2f2-2413-4d28-83b2-0808d0917b4dBiOFREEZE ®Reckitt Benckiser LLC20260513
939dbbc3-71ec-4990-840e-7c9b8d430562Biofreeze ® ColorlessReckitt Benckiser LLC20260513
a8d59d45-0e85-43d1-affd-bbe922c4acb1Biofreeze Colorless Roll-OnReckitt Benckiser LLC20260513
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fbBiofreeze ® Roll-OnRB Health (US) LLC20260325
4d3dcb8f-2075-6bbc-e063-6394a90a4992BioFreeze Day & Overnight Roll-OnRB Health (US) LLC20260317
cc1cba14-da40-4d7d-b522-b5c648798e96Biofreeze ® ColorlessA-S Medication Solutions20241111
814b37ea-5441-4cec-8794-71ca01d849aeBiofreeze ® Roll-OnA-S Medication Solutions20231030
f0c4d165-a242-4fb5-b2de-d64a825a29e9Biofreeze GelPerformance Health, LLC20181107

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_STRENGTH0.04 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD12742
CODESRxCUI1111683
CODESSPL_SET_ID4d3dcb8f-2075-6bbc-e063-6394a90a4992
CODESSPL_SET_ID814b37ea-5441-4cec-8794-71ca01d849ae
CODESSPL_SET_ID83d5c2f2-2413-4d28-83b2-0808d0917b4d
CODESSPL_SET_ID939dbbc3-71ec-4990-840e-7c9b8d430562
CODESSPL_SET_IDa8d59d45-0e85-43d1-affd-bbe922c4acb1
CODESSPL_SET_IDcc1cba14-da40-4d7d-b522-b5c648798e96
CODESSPL_SET_IDebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb
CODESSPL_SET_IDf0c4d165-a242-4fb5-b2de-d64a825a29e9
CODESSPL_SET_IDf5c8c08b-c7c0-f84d-e053-2a95a90add15
CODESSPL_SET_IDf67d7b7a-8922-73f6-e053-2995a90a2e80
NAMESPrescribable SynonymBIOFREEZE 4 % Topical Gel
NAMESRXNAV_STRBiofreeze 4 % Topical Gel
NAMESRxNorm Namementhol 0.04 MG/MG Topical Gel [Biofreeze]
NAMESRxNorm SynonymBiofreeze 0.04 MG/MG Topical Gel
NAMESRxNorm SynonymBiofreeze 4 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon