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

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 Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415975, 1794892

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

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