Home NDC 59316-004 Biofreeze Flexible Relief Strip
Product NDC 59316-004
11-digit product format 593160004
Labeler code 59316
Product ID 59316-004_51b597cc-806d-e160-e063-6394a90ac1be
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-31
Substance MENTHOL, UNSPECIFIED FORM
Active strength 56 mg/g
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 Flexible Relief Strip
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 56 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2566836 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 59316-004-01 Biofreeze Flexible Relief Strip 6 g in 1 PATCH PATCH 6 5 59316-004-01 Biofreeze Flexible Relief Strip 1 in 1 POUCH PATCH 1 5 59316-004-04 Biofreeze Flexible Relief Strip 4 in 1 CARTON PATCH 4 5 59316-004-04 Biofreeze Flexible Relief Strip 6 g in 1 PATCH PATCH 6 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-004 BIOFREEZE FLEXIBLE RELIEF STRIP (MENTHOL) PATCH [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 4 package rows 20241228_6ec26bae-e395-49aa-969e-8c653d6f0b27.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 48 of 152 · 3,029 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 59316-004-01 59316000401 1 PATCH in 1 POUCH (59316-004-01) / 6 g in 1 PATCH 1 patch 2021-03-31 0000-00-00 No No Current 59316-004-04 59316000404 4 PATCH in 1 CARTON (59316-004-04) / 6 g in 1 PATCH 4 patch 2021-03-31 0000-00-00 No No Current