Biofreeze

Product NDC
59316-114
11-digit product format
593160114
Labeler code
59316
Product ID
59316-114_51b43faa-c82a-4053-e063-6294a90a3c20
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-19
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
105 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 FORM105 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1489073, 1489074

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-114-10Biofreeze89 mL in 1 BOTTLESPRAY8921
59316-114-25Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11821
59316-114-30Biofreeze473 mL in 1 BOTTLE, SPRAYSPRAY47321
59316-114-50Biofreeze1 mL in 1 PACKETSPRAY121
59316-114-50Biofreeze10 in 1 BOXSPRAY1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-114-10ML - Milliliter59316-11434d03209-6552-449d-85d4-80c70328794812018-09-05
59316-114-25ML - Milliliter59316-114cf2515ba-bce7-4676-bd56-90f07f8450f712024-08-12
59316-114-30ML - Milliliter59316-11418baaf7f-09d9-4346-8fb2-3dbcf47bf5a112024-08-12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-114BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]20Current NDC, Legacy NDC, 5 package rows20241228_4c798b06-6ee5-41d1-8a14-f6889512ade3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489074BIOFREEZE 10.5 % Topical SprayPSN4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 10.5 % Topical SprayPSN4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074menthol 105 MG/ML Topical Spray [Biofreeze]SBD4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 105 MG/ML Topical SpraySCD4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074Biofreeze 10.5 % Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321
1489074Biofreeze 105 MG/ML Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321
1489073menthol 10.5 % Topical SpraySY4c798b06-6ee5-41d1-8a14-f6889512ade321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-114-105931601141089 mL in 1 BOTTLE (59316-114-10) 89 ml2016-09-190000-00-00NoNoCurrent
59316-114-2559316011425118 mL in 1 BOTTLE, SPRAY (59316-114-25) 118 ml2014-02-190000-00-00NoNoCurrent
59316-114-3059316011430473 mL in 1 BOTTLE, SPRAY (59316-114-30) 473 ml2014-02-190000-00-00NoNoCurrent
59316-114-505931601145010 PACKET in 1 BOX (59316-114-50) > 1 mL in 1 PACKET10 packet2014-02-192021-12-31NoNoCurrent