NDC 0485-0208

ED BRON GP

Guaifenesin And Phenylephrine

ED BRON GP is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 0485-0208_43f06e29-011d-4c45-96a2-c15fa4d90bac
• NDC: 0485-0208
• Product Type: Human Otc Drug
• Proprietary Name: ED BRON GP
• Generic Name: Guaifenesin And Phenylephrine
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-01
• Marketing Category: OTC MONOGRAPH FINAL / UNAPPROVED DRUG OTHER
• Application Number: part341
• Labeler Name: EDWARDS PHARMACEUTICALS, INC.
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0485-0208-16

473 mL in 1 BOTTLE, PLASTIC (0485-0208-16)

• Marketing Start Date: 2012-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0208-16 [00485020816]

ED BRON GP LIQUID

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-06-01

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	100 mg/5mL

OpenFDA Data

• SPL SET ID: b1fca5aa-d877-45e0-b074-dcbc6af94ee3
• Manufacturer:
  • EDWARDS PHARMACEUTICALS, INC.
• UNII:
  • 1WS297W6MV
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1358627