NDC 49580-0416

Severe cold and flu Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci

Severe cold and flu Nighttime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 49580-0416_3d17d8b1-fdde-4b3c-8aac-948d8d4f934f
• NDC: 49580-0416
• Product Type: Human Otc Drug
• Proprietary Name: Severe cold and flu Nighttime
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: P & L Development, LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49580-0416-8

237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)

• Marketing Start Date: 2015-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49580-0416-8 [49580041608]

Severe cold and flu Nighttime LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-08-31
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: 7c92bdcf-db1f-4299-982f-6a3da9cba6e6
• Manufacturer:
  • P & L Development, LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1431245
• UPC Code:
  • 0349580416086

NDC Crossover Matching brand name "Severe cold and flu Nighttime" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci"

NDC	Brand Name	Generic Name
11673-677	Severe Cold and Flu nighttime	Severe Cold and Flu nighttime
49580-0515	Cold Max	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
49580-0416	Severe cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
49580-4160	Severe cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
55319-416	Severe cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
55910-716	Severe cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI