Home NDC 53329-984 ActivICE
Product NDC 53329-984
11-digit product format 533290984
Labeler code 53329
Product ID 53329-984_5a6e9886-23df-e0ee-e063-6294a90a5e48
Type HUMAN OTC DRUG
Nonproprietary name menthol
Dosage form GEL
Route TOPICAL
Labeler Medline Industries, LP
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-04
Substance MENTHOL
Active strength 80 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 80 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283257 Internal RxNorm lookup 2119857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-984 ACTIVICE (MENTHOL) GEL [MEDLINE INDUSTRIES, LP] 10 Current NDC, Legacy NDC, 7 package rows 20241215_834adeb9-38ad-0cfe-e053-2991aa0af82f.zip 53329-984 DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC] 1 Current NDC, Legacy NDC 20200126_9d0012ed-a50a-a936-e053-2995a90a6100.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 77 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 53329-984-04 53329098404 118 mL in 1 TUBE (53329-984-04) 118 ml 2019-03-04 0000-00-00 No No Current 53329-984-06 53329098406 473 mL in 1 BOTTLE (53329-984-06) 473 ml 2019-03-04 0000-00-00 No No Current 53329-984-16 53329098416 5.6 mL in 1 PACKET (53329-984-16) 5.6 ml 2019-03-04 0000-00-00 No No Current 53329-984-23 53329098423 946 mL in 1 BOTTLE (53329-984-23) 946 ml 2019-03-04 0000-00-00 No No Current 53329-984-25 53329098425 3785 mL in 1 BOTTLE (53329-984-25) 3785 ml 2019-03-04 0000-00-00 No No Current 53329-984-30 53329098430 100 PACKET in 1 BOX (53329-984-30) / 5.6 mL in 1 PACKET 100 packet 2019-03-04 0000-00-00 No No Current