FDA.reportPublic FDA data

Biofreeze Roll-On

Product NDC
59316-205
11-digit product format
593160205
Labeler code
59316
Product ID
59316-205_51e07cc8-7357-2dce-e063-6394a90af835
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-17
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
40 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 Roll-On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415974, 1111683

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-205-09Biofreeze Roll-On37 mL in 1 BOTTLEGEL3721
59316-205-10Biofreeze Roll-On89 mL in 1 BOTTLEGEL8921
59316-205-14Biofreeze Roll-On74 mL in 1 BOTTLEGEL7421
59316-205-81Biofreeze Roll-On2 in 1 CARTONGEL221
59316-205-82Biofreeze Roll-On2 in 1 CARTONGEL221
59316-205-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-205-10ML - Milliliter59316-20514d40e2b-5615-41bd-a594-c7c596c2427b12024-06-10
59316-205-14ML - Milliliter59316-205cd2e340d-0c11-4803-a4f5-ecfbd7e195ce12022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-205BIOFREEZE ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]18Current NDC, Legacy NDC, 5 package rows20240323_ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSNebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
415974menthol 4 % Topical GelPSNebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
415974menthol 0.04 MG/MG Topical GelSCDebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
1111683Biofreeze 0.04 MG/MG Topical GelSYebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
1111683Biofreeze 4 % Topical GelSYebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
415974menthol 4 % Topical GelSYebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb21
1111683BIOFREEZE 4 % Topical GelPSN4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 4 % Topical GelPSN4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 0.04 MG/MG Topical GelSCD4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683Biofreeze 0.04 MG/MG Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683Biofreeze 4 % Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
415974menthol 4 % Topical GelSY4d3dcb8f-2075-6bbc-e063-6394a90a49925
1111683BIOFREEZE 4 % Topical GelPSN814b37ea-5441-4cec-8794-71ca01d849ae3
415974menthol 4 % Topical GelPSN814b37ea-5441-4cec-8794-71ca01d849ae3
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD814b37ea-5441-4cec-8794-71ca01d849ae3
415974menthol 0.04 MG/MG Topical GelSCD814b37ea-5441-4cec-8794-71ca01d849ae3
1111683Biofreeze 0.04 MG/MG Topical GelSY814b37ea-5441-4cec-8794-71ca01d849ae3
1111683Biofreeze 4 % Topical GelSY814b37ea-5441-4cec-8794-71ca01d849ae3
415974menthol 4 % Topical GelSY814b37ea-5441-4cec-8794-71ca01d849ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-205-095931602050937 mL in 1 BOTTLE (59316-205-09) 37 ml2024-03-15NoNoHistorical
59316-205-105931602051089 mL in 1 BOTTLE (59316-205-10) 89 ml2013-01-170000-00-00NoNoCurrent
59316-205-145931602051474 mL in 1 BOTTLE (59316-205-14) 74 ml2013-01-170000-00-00NoNoCurrent
59316-205-81593160205812 BOTTLE in 1 CARTON (59316-205-81) / 89 mL in 1 BOTTLE (59316-205-10) 2 bottle2022-02-220000-00-00NoNoCurrent
59316-205-82593160205822 BOTTLE in 1 CARTON (59316-205-82) / 89 mL in 1 BOTTLE (59316-205-10) 2 bottle2024-03-25NoNoHistorical