NDC 52083-481

Dologen

Dexbrompheniramine Maleate, Acetaminophen

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: 52083-481_ddc31276-446c-42f4-9558-04c7c6bff944
• NDC: 52083-481
• Product Type: Human Otc Drug
• Proprietary Name: Dologen
• Generic Name: Dexbrompheniramine Maleate, Acetaminophen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-10-11
• 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 52083-481-02

2 TABLET in 1 PACKET (52083-481-02)

• Marketing Start Date: 2011-10-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-481-02 [52083048102]

Dologen TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-10-11

NDC 52083-481-90 [52083048190]

Dologen TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-11

Drug Details

Active Ingredients

Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	2 mg/1

OpenFDA Data

• SPL SET ID: f8490040-51cd-4825-aea7-09a618437d29
• Manufacturer:
  • Kramer Novis
• UNII:
  • 362O9ITL9D
  • BPA9UT29BS
• RxNorm Concept Unique ID - RxCUI:
  • 1242042
  • 1190931

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

NDC	Brand Name	Generic Name
52083-481	Dologen	Dexbrompheniramine Maleate, Acetaminophen
63102-402	ACTIDOGESIC	Dexbrompheniramine maleate, acetaminophen