Home NDC 59316-005 Biofreeze Overnight Relief
Product NDC 59316-005
11-digit product format 593160005
Labeler code 59316
Product ID 59316-005_51e06e35-8e98-7ff9-e063-6294a90a2dff
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Unspecified Form
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-01
Substance MENTHOL, UNSPECIFIED FORM
Active strength .3 g/6g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Biofreeze Overnight Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM .3 g/6g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 420222 Internal RxNorm lookup 2109627 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-005-03 Biofreeze Overnight Relief 6 g in 1 PATCH PATCH 6 4 59316-005-04 Biofreeze Overnight Relief 4 in 1 CARTON PATCH 4 4 59316-005-04 Biofreeze Overnight Relief 6 g in 1 PATCH PATCH 6 4 59316-005-03 Biofreeze Day and Overnight 6 g in 1 PATCH PATCH 18 g in 3 0.3 g in 6g 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-005 BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC 20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.zip 59316-005 BIOFREEZE OVERNIGHT RELIEF (MENTHOL, UNSPECIFIED FORM) PATCH [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC, 3 package rows 20231214_07be6e88-1850-4d6a-946d-f03830b8c4a2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 77 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59316-005-03 59316000503 6 g in 1 PATCH (59316-005-03) 6 g 2022-02-01 0000-00-00 No No Current 59316-005-04 59316000504 4 PATCH in 1 CARTON (59316-005-04) / 6 g in 1 PATCH 4 patch 2022-02-01 0000-00-00 No No Current