Home NDC 53329-996 ActivICE
Product NDC 53329-996
11-digit product format 533290996
Labeler code 53329
Product ID 53329-996_41d71f1f-b6a8-5401-e063-6294a90a19d3
Type HUMAN OTC DRUG
Nonproprietary name menthol
Dosage form SPRAY
Route TOPICAL
Labeler Medline Industries, LP
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-01
Substance MENTHOL
Active strength 100 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 ActivICE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 100 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 667889 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 53329-996-04 ActivICE 118 mL in 1 BOTTLE SPRAY 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-996 ACTIVICE (MENTHOL) SPRAY [MEDLINE INDUSTRIES, LP] 5 Current NDC, Legacy NDC, 1 package rows 20241215_98fa9a34-0e1e-0997-e053-2a95a90ac77d.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 53329-996-04 53329099604 118 mL in 1 BOTTLE (53329-996-04) 118 ml 2020-01-01 0000-00-00 No No Current