Home NDC 63102-401 ACTICON
Product NDC 63102-401
11-digit product format 631020401
Labeler code 63102
Product ID 63102-401_fa228895-52c1-44e7-b53c-fad106868c0d
Type HUMAN OTC DRUG
Nonproprietary name DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-08-13
Substance DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 2; 60 mg/1; mg/1
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/1 PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1
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 1363513 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63102-401-60 ACTICON 60 in 1 BOTTLE, PLASTIC TABLET 60 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXBROMPHENIRAMINE MALEATE ACTIVE INGREDIENT BPA9UT29BS ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 DEXBROMPHENIRAMINE ACTIVE MOIETY 75T64B71RP ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-401 ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240814_847014ab-86ae-40c5-8e7f-f1ddea14f1b3.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 63102-401-60 63102040160 60 TABLET in 1 BOTTLE, PLASTIC (63102-401-60) 60 tablet 2015-08-13 0000-00-00 No No Current