NDC 55315-004

Night Time Severe Cold and Cough

Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl

Night Time Severe Cold and Cough is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 55315-004_0d56bd18-734d-4960-bad8-3150ff544d36
• NDC: 55315-004
• Product Type: Human Otc Drug
• Proprietary Name: Night Time Severe Cold and Cough
• Generic Name: Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Fred's, Inc.
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55315-004-33

245.5 mL in 1 BOTTLE (55315-004-33)

• Marketing Start Date: 2016-06-09
• Marketing End Date: 2022-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55315-004-33 [55315000433]

Night Time Severe Cold and Cough SYRUP

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-09

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: d773c939-b959-4dff-8a82-b085f2acb32c
• Manufacturer:
  • Fred's, Inc.
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1298348

NDC Crossover Matching brand name "Night Time Severe Cold and Cough" or generic name "Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl"

NDC	Brand Name	Generic Name
55315-004	Night Time Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
55319-977	Night Time Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
59779-583	Allergy and Cold	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
55301-464	Allergy and Sinus Headache	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
33992-0464	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
55910-464	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
58602-120	AuroFlu Flu and Sore Throat Warming Relief	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
58602-161	AuroFlu Night Time Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
58602-140	AuroFlu Night Time Severe Cold and Cough Warming Relief	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
58602-150	AuroMucus Fast Maximum Night Time Cold and Flu	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
64525-0562	Best Choice Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL
59779-221	CVS Pharmacy Nighttime Severe Cough and Cold	Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
64525-0566	Family Dollar Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
10202-947	Fast Maximum Night Time Cold and Flu	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
64525-0558	Meijer Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL
63868-764	Quality Choice Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL
11822-5260	severe cold and sinus relief PE	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
64525-0560	Smart sense Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL
36800-800	TopCare Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
0363-0526	Wal-Phed	Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
64525-0564	Western Family Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
67091-143	WinCo Foods Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL