NDC 52083-681

G-Dologen

Acetaminophen, Dexbrompheniramine Maleate

G-Dologen is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dexbrompheniramine Maleate; Acetaminophen.

Product ID52083-681_4cb59387-f450-457d-bc0b-571a7a408c2a
NDC52083-681
Product TypeHuman Otc Drug
Proprietary NameG-Dologen
Generic NameAcetaminophen, Dexbrompheniramine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-08-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKRAMER NOVIS
Substance NameDEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN
Active Ingredient Strength2 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-681-90

90 TABLET in 1 BOTTLE (52083-681-90)
Marketing Start Date2014-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-681-90 [52083068190]

G-Dologen TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-08-27

Drug Details

Active Ingredients

IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1

OpenFDA Data

SPL SET ID:1bd74da3-9c5b-46e9-b599-999cd6eac1d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1242042
  • 1190931
  • NDC Crossover Matching brand name "G-Dologen" or generic name "Acetaminophen, Dexbrompheniramine Maleate"

    NDCBrand NameGeneric Name
    52083-681G-Dologenacetaminophen, dexbrompheniramine maleate
    63102-403ACTIDOGESIC DFAcetaminophen, Dexbrompheniramine Maleate
    45737-610BiogesicAcetaminophen, Dexbrompheniramine Maleate
    54859-001DologesicAcetaminophen, Dexbrompheniramine Maleate
    54859-010DologesicAcetaminophen, Dexbrompheniramine Maleate

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