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 ID: 52083-681_4cb59387-f450-457d-bc0b-571a7a408c2a
• NDC: 52083-681
• Product Type: Human Otc Drug
• Proprietary Name: G-Dologen
• Generic Name: Acetaminophen, Dexbrompheniramine Maleate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-27
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: KRAMER NOVIS
• Substance Name: DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN
• Active Ingredient Strength: 2 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52083-681-90

90 TABLET in 1 BOTTLE (52083-681-90)

• Marketing Start Date: 2014-08-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-681-90 [52083068190]

G-Dologen TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-27

Drug Details

Active Ingredients

Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	2 mg/1

OpenFDA Data

• SPL SET ID: 1bd74da3-9c5b-46e9-b599-999cd6eac1d8
• Manufacturer:
  • KRAMER NOVIS
• UNII:
  • 362O9ITL9D
  • BPA9UT29BS
• RxNorm Concept Unique ID - RxCUI:
  • 1242042
  • 1190931

NDC Crossover Matching brand name "G-Dologen" or generic name "Acetaminophen, Dexbrompheniramine Maleate"

NDC	Brand Name	Generic Name
52083-681	G-Dologen	acetaminophen, dexbrompheniramine maleate
63102-403	ACTIDOGESIC DF	Acetaminophen, Dexbrompheniramine Maleate
45737-610	Biogesic	Acetaminophen, Dexbrompheniramine Maleate
54859-001	Dologesic	Acetaminophen, Dexbrompheniramine Maleate
54859-010	Dologesic	Acetaminophen, Dexbrompheniramine Maleate