Home NDC 63102-108 ACTICON
Product NDC 63102-108
11-digit product format 631020108
Labeler code 63102
Product ID 63102-108_5bfc3584-960d-4fde-a4ea-03b3c9eb0293
Type HUMAN OTC DRUG
Nonproprietary name Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-15
Substance DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 2; 60 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 ACTICON
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXBROMPHENIRAMINE MALEATE 2 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BPA9UT29BS Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2592643 Internal RxNorm 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 63102-108-16 ACTICON 474 mL in 1 BOTTLE, PLASTIC SOLUTION 474 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-108 ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240814_aea0335d-75e6-4a90-86a5-f197cf024a11.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 74 of 180 · 3,583 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 63102-108-16 63102010816 474 mL in 1 BOTTLE, PLASTIC (63102-108-16) 474 ml 2022-02-15 0000-00-00 No No Current