Home NDC 63102-403 ACTIDOGESIC DF
Product NDC 63102-403
11-digit product format 631020403
Labeler code 63102
Product ID 63102-403_d024a896-b400-4d33-a6aa-9643f823d4e2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dexbrompheniramine Maleate
Dosage form TABLET
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-10
Substance ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength 500; 1 mg/1; mg/1
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 ACTIDOGESIC DF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DEXBROMPHENIRAMINE MALEATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup BPA9UT29BS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1798453 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63102-403-10 ACTIDOGESIC DF 100 in 1 BOTTLE, PLASTIC TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-403 ACTIDOGESIC DF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [ACTIPHARMA, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240809_ff8e2565-bce3-4c06-a416-6e8f369f057f.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 63102-403-10 63102040310 100 TABLET in 1 BOTTLE, PLASTIC (63102-403-10) 100 tablet 2020-07-10 0000-00-00 No No Current