Home NDC 57337-052 XtraCare Ice Cold Topical Analgesic Gel
Product NDC 57337-052
11-digit product format 573370052
Labeler code 57337
Product ID 57337-052_087f5ceb-0e96-0c3a-e063-6394a90acfc7
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Rejoice International
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-01-30
Substance MENTHOL
Active strength 3 g/227g
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 XtraCare Ice Cold Topical Analgesic Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 3 g/227g
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 866128 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-052-01 XtraCare Ice Cold Topical Analgesic Gel 227 g in 1 BOTTLE GEL 227 9 57337-052-02 XtraCare Ice Cold Topical Analgesic Gel 227 g in 1 TUBE GEL 227 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-052 XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL] 9 Current NDC, Legacy NDC, 2 package rows 20231025_d38f3099-d940-44d8-aa7f-404157c5e0e3.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 18 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 57337-052-01 57337005201 227 g in 1 BOTTLE (57337-052-01) 227 g 2014-01-30 0000-00-00 No No Current 57337-052-02 57337005202 227 g in 1 TUBE (57337-052-02) 227 g 2014-01-30 No No Current