NDC 69729-782

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl

Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Opmx Llc. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Acetaminophen; Guaifenesin.

• Product ID: 69729-782_9a164cfc-b624-9a9f-e053-2a95a90a0173
• NDC: 69729-782
• Product Type: Human Otc Drug
• Proprietary Name: Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
• Generic Name: Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: OPMX LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69729-782-10

10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10)

• Marketing Start Date: 2019-02-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69729-782-10 [69729078210]

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-02-18

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 9a164cfc-b623-9a9f-e053-2a95a90a0173
• Manufacturer:
  • OPMX LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1656815

NDC Crossover Matching brand name "Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
55629-015	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
69729-782	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
68016-224	Childrens Cold, Cough and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
69732-003	Head and Cold	acetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl