NDC 36800-509

Cough Relief Adult

Dextromethorphan Hbr

Cough Relief Adult is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Top Care (topco Associates Llc). The primary component is Dextromethorphan Hydrobromide.

• Product ID: 36800-509_03489b61-4a19-4309-a6f4-0eb4e7af62ea
• NDC: 36800-509
• Product Type: Human Otc Drug
• Proprietary Name: Cough Relief Adult
• Generic Name: Dextromethorphan Hbr
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: TOP CARE (Topco Associates LLC)
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 15 mg/5mL
• Pharm Classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 36800-509-04

1 BOTTLE, PLASTIC in 1 BOX (36800-509-04) > 118 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-509-04 [36800050904]

Cough Relief Adult LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: b2ebfeb3-e248-40bf-81d3-81c5fb532dbe
• Manufacturer:
  • TOP CARE (Topco Associates LLC)
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1090496
• UPC Code:
  • 0036800224506

NDC Crossover Matching brand name "Cough Relief Adult" or generic name "Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
46122-324	Cough Relief Adult	Cough Relief Adult
55315-309	Cough Relief Adult	Cough Relief Adult
55910-309	Cough Relief Adult	Cough Relief Adult
21130-383	Adult Cough Relief DM	Dextromethorphan HBr
0363-0500	Cough	Dextromethorphan HBr
15127-661	Cough Control	Dextromethorphan HBr
0363-8990	Cough Relief	DEXTROMETHORPHAN HBr
15127-309	Cough Relief	Dextromethorphan HBr
24385-262	Cough Relief	Dextromethorphan HBr
24385-263	Cough Relief	Dextromethorphan HBr
33992-0666	Cough Relief	Dextromethorphan HBr
36800-454	Cough Relief	Dextromethorphan HBr
36800-509	Cough Relief	Dextromethorphan HBr
0536-1323	Dextromethorphan HBr	Dextromethorphan HBr
0536-1334	Dextromethorphan HBr 15 mg Liquid Gels	Dextromethorphan HBr
0395-9126	Father Johns Medicine	Dextromethorphan HBr
0536-1068	Robafen Cough	Dextromethorphan HBr
0031-8741	ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS	dextromethorphan HBr
21130-635	Signature Care Daytime Cough	Dextromethorphan HBr
0363-6610	Wal-Tussin	Dextromethorphan HBr