NDC 36800-893

Topcare childrens cold cough and sore throat

Acetaminophen, Dextromethorphan Hydrobromide

Topcare childrens cold cough and sore throat is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

• Product ID: 36800-893_2efad63b-4a3d-4c2a-a8bd-a08fdf476696
• NDC: 36800-893
• Product Type: Human Otc Drug
• Proprietary Name: Topcare childrens cold cough and sore throat
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-13
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Topco Associates LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 160 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 36800-893-26

1 BOTTLE in 1 CARTON (36800-893-26) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2019-08-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-893-26 [36800089326]

Topcare childrens cold cough and sore throat SUSPENSION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-08-13

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: 467a8f31-c0bc-4a87-a0f0-dcc50c9a7c2f
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1370113

NDC Crossover Matching brand name "Topcare childrens cold cough and sore throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
36800-893	Topcare childrens cold cough and sore throat	acetaminophen, dextromethorphan Hydrobromide
0113-7101	Basic Care childrens cold and cough and sore throat	acetaminophen, dextromethorphan hydrobromide
69842-622	childrens cough and sore throat	acetaminophen, dextromethorphan Hydrobromide
11822-2023	childrens pain relief cold and cough and sore throat	acetaminophen, dextromethorphan hydrobromide
11523-0093	Coricidin HBP Maximum Strength Cold, Cough and Flu	acetaminophen, dextromethorphan hydrobromide
0363-0029	Cough and Sore Throat	Acetaminophen, Dextromethorphan hydrobromide
0031-8750	Robitussin Maximum Strength Severe Cough Plus Sore Throat	acetaminophen, dextromethorphan hydrobromide
37000-027	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide