NDC 51532-0140

Fedrin

Acetaminophen, Phenylephrine

Fedrin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Afassco Inc.. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

• Product ID: 51532-0140_8e9a098b-0113-45db-8a49-814ebdb4f303
• NDC: 51532-0140
• Product Type: Human Otc Drug
• Proprietary Name: Fedrin
• Generic Name: Acetaminophen, Phenylephrine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Afassco Inc.
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 500 1/1; 1/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 51532-0140-2

2 TABLET in 1 PACKET (51532-0140-2)

• Marketing Start Date: 2016-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51532-0140-2 [51532014002]

Fedrin TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	500 1/1

OpenFDA Data

• SPL SET ID: 05d80f93-020c-48a5-b72f-4a91908949b8
• Manufacturer:
  • Afassco Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1101534