Home NDC 53329-991 ActivICE
Product NDC 53329-991
11-digit product format 533290991
Labeler code 53329
Product ID 53329-991_26bebd7d-b1e7-5e7e-e063-6394a90a273a
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 2019-03-04
Substance MENTHOL
Active strength 80 g/1000g
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 80 g/1000g
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 351286 Internal RxNorm lookup 2119854 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 53329-991-04 ActivICE 113.4 g in 1 BOTTLE, SPRAY SPRAY 113.4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-991 ACTIVICE (MENTHOL) SPRAY [MEDLINE INDUSTRIES, LP] 6 Current NDC, Legacy NDC, 1 package rows 20241215_8414aea2-52b5-4221-e053-2a91aa0a622e.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 111 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 53329-991-04 53329099104 113.4 g in 1 BOTTLE, SPRAY (53329-991-04) 113.4 g 2019-03-04 0000-00-00 No No Current