NDC 58602-518

Childrens Cold, Cough and Sore Throat

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride

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

• Product ID: 58602-518_4891ac0d-790c-4bbf-aacf-67066a12eb8c
• NDC: 58602-518
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Cold, Cough and Sore Throat
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-03
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Aurohealth LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58602-518-24

118 mL in 1 BOTTLE (58602-518-24)

• Marketing Start Date: 2016-05-03
• Marketing End Date: 2022-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58602-518-24 [58602051824]

Childrens Cold, Cough and Sore Throat SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-05-03

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/10mL

OpenFDA Data

• SPL SET ID: d349e37f-bb74-4b49-bff9-e1c58d204d5e
• Manufacturer:
  • Aurohealth 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, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride"

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
58602-157	Auro Mucus - Childrens Cold, Cough and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-110	AuroMucus - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
69842-006	CVS - Childrens Mucus Relief Cough, Cold and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
67091-331	Fast Acting Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
49738-995	KMart - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-504	Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
50066-916	TUKOL MAX ACTION COLD SORE THROAT AND COUGH	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58933-540	Vicks DayQuil Severe Hot Remedy	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
69423-976	Vicks DayQuil Severe Hot Remedy	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
0363-8592	Walgreens Severe Warming Cold and Flu For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride