Biofreeze Colorless

Product NDC
59316-103
11-digit product format
593160103
Labeler code
59316
Product ID
59316-103_51b597cc-8068-e160-e063-6394a90ac1be
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
2012-01-03
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
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
59316-103-10Biofreeze Colorless5 mL in 1 BOTTLEGEL531
59316-103-11Biofreeze Colorless3 mL in 1 BOTTLEGEL331
59316-103-12Biofreeze Colorless89 mL in 1 BOTTLEGEL8931
59316-103-15Biofreeze Colorless89 mL in 1 BOTTLE, WITH APPLICATORGEL8931
59316-103-20Biofreeze Colorless118 mL in 1 BOTTLEGEL11831
59316-103-28Biofreeze Colorless273 mL in 1 BOTTLEGEL27331
59316-103-40Biofreeze Colorless946 mL in 1 BOTTLEGEL94631

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-103-12ML - Milliliter59316-103b52397a8-ed9d-4dc6-b82e-39964b2d6c6a12018-05-09
59316-103-20ML - Milliliter59316-103700d69bb-759b-4ca7-941b-78f7b222594012024-06-10
59316-103-40ML - Milliliter59316-1030770d763-3f20-4da3-91bb-9cc65a6fddcf12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-103BIOFREEZE COLORLESS (MENTHOL) GEL [RB HEALTH (US) LLC]30Current NDC, Legacy NDC, 7 package rows20241228_939dbbc3-71ec-4990-840e-7c9b8d430562.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSN939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 4 % Topical GelPSN939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 0.04 MG/MG Topical GelSCD939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683Biofreeze 0.04 MG/MG Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683Biofreeze 4 % Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
415974menthol 4 % Topical GelSY939dbbc3-71ec-4990-840e-7c9b8d43056231
1111683BIOFREEZE 4 % Topical GelPSNcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 4 % Topical GelPSNcc1cba14-da40-4d7d-b522-b5c648798e964
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 0.04 MG/MG Topical GelSCDcc1cba14-da40-4d7d-b522-b5c648798e964
1111683Biofreeze 0.04 MG/MG Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964
1111683Biofreeze 4 % Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964
415974menthol 4 % Topical GelSYcc1cba14-da40-4d7d-b522-b5c648798e964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-103-10593160103105 mL in 1 BOTTLE5 mlHistorical
59316-103-11593160103113 mL in 1 BOTTLE (59316-103-11) 3 ml2012-01-032021-12-31NoNoCurrent
59316-103-125931601031289 mL in 1 BOTTLE (59316-103-12) 89 ml2016-09-190000-00-00NoNoCurrent
59316-103-155931601031589 mL in 1 BOTTLE, WITH APPLICATOR89 mlHistorical
59316-103-2059316010320118 mL in 1 BOTTLE (59316-103-20) 118 ml2012-01-030000-00-00NoNoCurrent
59316-103-2859316010328273 mL in 1 BOTTLE273 mlHistorical
59316-103-4059316010340946 mL in 1 BOTTLE (59316-103-40) 946 ml2012-01-030000-00-00NoNoCurrent