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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact 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