Home NDC 0363-0355 Overnight Cold Therapy Pain Relief
Product NDC 0363-0355
11-digit product format 003630355
Labeler code 0363
Product ID 0363-0355_5f845434-d8db-4bfa-8fc0-8a9b9205f194
Type HUMAN OTC DRUG
Nonproprietary name Menthol, unspecified form
Dosage form GEL
Route TOPICAL
Labeler Walgreen Co.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-04
Substance MENTHOL, UNSPECIFIED FORM
Active strength 36 mg/mL
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 Overnight Cold Therapy Pain Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 36 mg/mL
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 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 0363-0355-03 Overnight Cold Therapy Pain Relief 89 mL in 1 TUBE GEL 89 2 0363-0355-25 Overnight Cold Therapy Pain Relief 74 mL in 1 BOTTLE, WITH APPLICATOR GEL 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0355 OVERNIGHT COLD THERAPY PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [WALGREEN CO.] 2 Current NDC, 2 package rows 20231216_2cbd0966-4cf9-4271-bd53-6672b1ed2a99.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0363-0355-03 00363035503 89 mL in 1 TUBE (0363-0355-03) 89 ml 2023-12-04 No No Current 0363-0355-25 00363035525 74 mL in 1 BOTTLE, WITH APPLICATOR (0363-0355-25) 74 ml 2023-12-04 No No Current