BIOFREEZE

Product NDC
59316-102
11-digit product format
593160102
Labeler code
59316
Product ID
59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
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
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
59316-102-10BIOFREEZE5 mL in 1 BOTTLEGEL535
59316-102-11BIOFREEZE3 mL in 1 BOTTLEGEL335
59316-102-12BIOFREEZE89 mL in 1 BOTTLEGEL8935
59316-102-15BIOFREEZE89 mL in 1 BOTTLE, WITH APPLICATORGEL8935
59316-102-16BIOFREEZE89 mL in 1 BOTTLE, WITH APPLICATORGEL8935
59316-102-20BIOFREEZE118 mL in 1 BOTTLEGEL11835
59316-102-25BIOFREEZE118 mL in 1 BOTTLE, WITH APPLICATORGEL11835
59316-102-28BIOFREEZE237 mL in 1 BOTTLEGEL23735
59316-102-30BIOFREEZE473 mL in 1 BOTTLEGEL47335
59316-102-40BIOFREEZE946 mL in 1 BOTTLEGEL94635
59316-102-50BIOFREEZE3785 mL in 1 CONTAINERGEL378535
59316-102-80BIOFREEZE44 mL in 1 TUBEGEL4435
59316-102-90BIOFREEZE100 in 1 CARTONGEL10035
59316-102-91BIOFREEZE10 in 1 CARTONGEL1035
59316-102-92BIOFREEZE16 in 1 CARTONGEL1635
59316-102-98BIOFREEZE30 mL in 1 BOTTLEGEL3035
59316-102-80Biofreeze44 mL in 1 TUBEGEL441

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-102-12ML - Milliliter59316-1028c11b8a5-4f02-41bf-88b6-e4af8c4214f812018-09-05
59316-102-20ML - Milliliter59316-10263342204-7fd4-4732-9ec3-4df580a6e6ce12015-06-09
59316-102-28ML - Milliliter59316-102e8471990-bf89-42b8-8a43-721055ce764512018-09-05
59316-102-30ML - Milliliter59316-1028537e275-8662-4f2c-ae52-44981681af9912024-08-12
59316-102-40ML - Milliliter59316-102030b1aca-eae8-43da-9839-6522c8c985ac12024-08-12
59316-102-50ML - Milliliter59316-10235b2fa59-5fb2-4779-a89d-b84cda16782512024-08-12
59316-102-80ML - Milliliter59316-10239ef3edc-90e7-4701-bbcc-add710ddea6d12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
MENTHOLACTIVE MOIETYL7T10EIP3ABIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WMBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14
WATERINACTIVE INGREDIENT059QF0KO0RBIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-102BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]34Current NDC, Legacy NDC, 16 package rows20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip
59316-102BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1Current NDC, Legacy NDC, 1 package rows20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111683BIOFREEZE 4 % Topical GelPSN83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 4 % Topical GelPSN83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 0.04 MG/MG Topical GelSCD83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683Biofreeze 0.04 MG/MG Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683Biofreeze 4 % Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
415974menthol 4 % Topical GelSY83d5c2f2-2413-4d28-83b2-0808d0917b4d35
1111683BIOFREEZE 4 % Topical GelPSNf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 4 % Topical GelPSNf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBDf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 0.04 MG/MG Topical GelSCDf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683Biofreeze 0.04 MG/MG Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91
1111683Biofreeze 4 % Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91
415974menthol 4 % Topical GelSYf0c4d165-a242-4fb5-b2de-d64a825a29e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-102-10593160102105 mL in 1 BOTTLE (59316-102-10) 5 ml2012-01-030000-00-00NoNoCurrent
59316-102-11593160102113 mL in 1 BOTTLE (59316-102-11) 3 ml2012-01-030000-00-00NoNoCurrent
59316-102-125931601021289 mL in 1 BOTTLE (59316-102-12) 89 ml2016-09-190000-00-00NoNoCurrent
59316-102-155931601021589 mL in 1 BOTTLE, WITH APPLICATOR89 mlHistorical
59316-102-165931601021689 mL in 1 BOTTLE, WITH APPLICATOR89 mlHistorical
59316-102-2059316010220118 mL in 1 BOTTLE (59316-102-20) 118 ml2012-01-030000-00-00NoNoCurrent
59316-102-2559316010225118 mL in 1 BOTTLE, WITH APPLICATOR (59316-102-25) 118 ml2012-01-032021-12-31NoNoCurrent
59316-102-2859316010228237 mL in 1 BOTTLE (59316-102-28) 237 ml2016-09-190000-00-00NoNoCurrent
59316-102-3059316010230473 mL in 1 BOTTLE (59316-102-30) 473 ml2012-01-030000-00-00NoNoCurrent
59316-102-4059316010240946 mL in 1 BOTTLE (59316-102-40) 946 ml2012-01-030000-00-00NoNoCurrent
59316-102-50593160102503785 mL in 1 CONTAINER (59316-102-50) 3785 ml2012-01-030000-00-00NoNoCurrent
59316-102-805931601028044 mL in 1 TUBE (59316-102-80) 44 ml2018-11-020000-00-00NoNoCurrent
59316-102-9059316010290100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10) 100 bottle2012-01-030000-00-00NoNoCurrent
59316-102-915931601029110 BOTTLE in 1 CARTON (59316-102-91) > 3 mL in 1 BOTTLE (59316-102-11) 10 bottle2012-01-030000-00-00NoNoCurrent
59316-102-925931601029216 BOTTLE in 1 CARTON (59316-102-92) > 3 mL in 1 BOTTLE (59316-102-11) 16 bottle2012-01-030000-00-00NoNoCurrent
59316-102-985931601029830 mL in 1 BOTTLE (59316-102-98) 30 ml2012-01-030000-00-00NoNoCurrent