FDA.reportPublic FDA data

Biofreeze Professional

Product NDC
59316-115
11-digit product format
593160115
Labeler code
59316
Product ID
59316-115_51e07a73-db68-3e69-e063-6394a90a6bdb
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-03
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Professional
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415975Internal RxNorm lookup
1794892Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6bef9ccb-7a5a-4c67-b1bc-a92b167312daAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-115-11Biofreeze Professional3 mL in 1 PACKETGEL312
59316-115-20Biofreeze Professional118 mL in 1 TUBEGEL11812
59316-115-30Biofreeze Professional473 mL in 1 BOTTLEGEL47312
59316-115-40Biofreeze Professional946 mL in 1 BOTTLEGEL94612
59316-115-50Biofreeze Professional3785 mL in 1 BOTTLEGEL378512
59316-115-82Biofreeze Professional100 in 1 CARTONGEL10012
59316-115-82Biofreeze Professional3 mL in 1 PACKETGEL312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-115-20ML - Milliliter59316-1156bb636bf-c424-483f-a96c-25d573e887e112022-03-09
59316-115-30ML - Milliliter59316-115b8900c01-67f9-4986-9516-3b93c0a9f90412022-01-06
59316-115-40ML - Milliliter59316-11549c29547-36c8-4df3-a918-7ccd9b78214f12022-09-12
59316-115-50ML - Milliliter59316-115693a9dea-91e4-4573-9a86-f6c0b4ff138012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-115BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]11Current NDC, Legacy NDC, 7 package rows20231114_6bef9ccb-7a5a-4c67-b1bc-a92b167312da.zip

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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794892BIOFREEZE 5 % Topical GelPSN6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
415975menthol 5 % Topical GelPSN6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBD6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
415975menthol 0.05 MG/MG Topical GelSCD6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
1794892Biofreeze 5 % Topical GelSY6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
415975menthol 5 % Topical GelSY6bef9ccb-7a5a-4c67-b1bc-a92b167312da12
1794892BIOFREEZE 5 % Topical GelPSN66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 5 % Topical GelPSN66ff9726-20da-688a-e053-2a91aa0a59ac6
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBD66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 0.05 MG/MG Topical GelSCD66ff9726-20da-688a-e053-2a91aa0a59ac6
1794892Biofreeze 5 % Topical GelSY66ff9726-20da-688a-e053-2a91aa0a59ac6
415975menthol 5 % Topical GelSY66ff9726-20da-688a-e053-2a91aa0a59ac6
1794892BIOFREEZE 5 % Topical GelPSNcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 5 % Topical GelPSNcbeac814-59d8-4c13-8e73-bca66f797f8d3
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBDcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 0.05 MG/MG Topical GelSCDcbeac814-59d8-4c13-8e73-bca66f797f8d3
1794892Biofreeze 5 % Topical GelSYcbeac814-59d8-4c13-8e73-bca66f797f8d3
415975menthol 5 % Topical GelSYcbeac814-59d8-4c13-8e73-bca66f797f8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-115-11593160115113 mL in 1 PACKET (59316-115-11) 3 ml2016-06-030000-00-00NoNoCurrent
59316-115-2059316011520118 mL in 1 TUBE (59316-115-20) 118 ml2016-06-030000-00-00NoNoCurrent
59316-115-3059316011530473 mL in 1 BOTTLE (59316-115-30) 473 ml2016-06-030000-00-00NoNoCurrent
59316-115-4059316011540946 mL in 1 BOTTLE (59316-115-40) 946 ml2016-06-030000-00-00NoNoCurrent
59316-115-50593160115503785 mL in 1 BOTTLE (59316-115-50) 3785 ml2016-06-030000-00-00NoNoCurrent
59316-115-8259316011582100 PACKET in 1 CARTON (59316-115-82) / 3 mL in 1 PACKET100 packet2019-01-050000-00-00NoNoCurrent