Biofreeze Colorless Roll-On

Product NDC
59316-206
11-digit product format
593160206
Labeler code
59316
Product ID
59316-206_51b58e7e-a6c1-b40f-e063-6394a90a1f1e
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 Colorless 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-206-10Biofreeze Colorless Roll-On1 in 1 CARTONGEL110
59316-206-10Biofreeze Colorless Roll-On89 mL in 1 BOTTLE, WITH APPLICATORGEL8910

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-206-10ML - Milliliter59316-2067d320a39-8167-4221-b750-d09fba2f868312024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-206BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]9Current NDC, Legacy NDC, 2 package rows20241228_a8d59d45-0e85-43d1-affd-bbe922c4acb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSNa8d59d45-0e85-43d1-affd-bbe922c4acb110
415974menthol 4 % Topical GelPSNa8d59d45-0e85-43d1-affd-bbe922c4acb110
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDa8d59d45-0e85-43d1-affd-bbe922c4acb110
415974menthol 0.04 MG/MG Topical GelSCDa8d59d45-0e85-43d1-affd-bbe922c4acb110
1111683Biofreeze 0.04 MG/MG Topical GelSYa8d59d45-0e85-43d1-affd-bbe922c4acb110
1111683Biofreeze 4 % Topical GelSYa8d59d45-0e85-43d1-affd-bbe922c4acb110
415974menthol 4 % Topical GelSYa8d59d45-0e85-43d1-affd-bbe922c4acb110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59316-206-10593160206101 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) / 89 mL in 1 BOTTLE, WITH APPLICATOR2013-01-170000-00-00NoNoCurrent