NDC 68016-224

Childrens Cold, Cough and Sore Throat

Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl

Childrens Cold, Cough and Sore Throat is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Chain Drug Consortium, Llc. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 68016-224_7c8f6aa5-051e-413c-97e1-480a66e7b0cd
• NDC: 68016-224
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Cold, Cough and Sore Throat
• Generic Name: Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: Chain Drug Consortium, LLC
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68016-224-00

118 mL in 1 BOTTLE (68016-224-00)

• Marketing Start Date: 2013-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68016-224-00 [68016022400]

Childrens Cold, Cough and Sore Throat LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/10mL

OpenFDA Data

• SPL SET ID: b3cd548b-9b49-4dac-bd0f-30ee71bacb3f
• Manufacturer:
  • Chain Drug Consortium, LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1116572

NDC Crossover Matching brand name "Childrens Cold, Cough and Sore Throat" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
58602-518	Childrens Cold, Cough and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
68016-224	Childrens Cold, Cough and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
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
69732-003	Head and Cold	acetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl