NDC 49580-0378

DayTime Cold and Cough Childrens

Dextromethorphan Hbr, Phenylephrine Hcl

DayTime Cold and Cough Childrens is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 49580-0378_12a4634f-7ced-4a1e-b5c0-5303c846d15d
• NDC: 49580-0378
• Product Type: Human Otc Drug
• Proprietary Name: DayTime Cold and Cough Childrens
• Generic Name: Dextromethorphan Hbr, Phenylephrine Hcl
• 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: P & L Development, LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49580-0378-4

118 mL in 1 BOTTLE, PLASTIC (49580-0378-4)

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

NDC SPL Data Element Entries

NDC 49580-0378-4 [49580037804]

DayTime Cold and Cough Childrens 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	5 mg/5mL

OpenFDA Data

• SPL SET ID: 7d8ccd41-115f-4db7-a978-6775411c5f95
• Manufacturer:
  • P & L Development, LLC
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1544873
• UPC Code:
  • 0349580378049

NDC Crossover Matching brand name "DayTime Cold and Cough Childrens" or generic name "Dextromethorphan Hbr, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
53145-026	Broncofin	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
63941-378	Childrens Day Time Cold and Cough	Dextromethorphan HBr, Phenylephrine HCl
55319-378	Cold and Cough Day Time	Dextromethorphan HBr, Phenylephrine HCl
49580-0378	DayTime Cold and Cough	Dextromethorphan HBr, Phenylephrine HCl
69842-378	Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
76864-464	Pulmo Calcio	DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
41520-378	Triacting Day Time Cold and Cough	Dextromethorphan HBr, Phenylephrine HCl
46122-327	Triacting Day Time Cold and Cough	Dextromethorphan HBr, Phenylephrine HCl
0363-3780	Triacting Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
21130-378	Triacting Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
24385-981	Triacting Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
55910-378	Triacting Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
63868-369	Triacting Daytime Cold Cough	Dextromethorphan HBr, Phenylephrine HCl
0067-8105	Triaminic	Dextromethorphan HBr, Phenylephrine HCl