Home NDC 52083-683 G-DOLOGEN
Product NDC 52083-683
11-digit product format 520830683
Labeler code 52083
Product ID 52083-683_cb33b7c4-d41e-450e-b731-77fc4f8e1720
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dexbrompheniramine maleate
Dosage form TABLET
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-15
Substance ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength 500; 2 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 G-DOLOGEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DEXBROMPHENIRAMINE MALEATE 2 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 2729424 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 52083-683-90 G-DOLOGEN 90 in 1 BOTTLE, PLASTIC TABLET 90 1
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 123 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 Sample Exclude flag Status 52083-683-90 52083068390 90 TABLET in 1 BOTTLE, PLASTIC (52083-683-90) 90 tablet 2025-12-15 No No Current