NDC 68163-541

Nighttime Severe Cold and Cough

Acetaminophen, Diphenhydramine, Phenylephrine

Nighttime Severe Cold and Cough is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Raritan Pharmaceuticals Inc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 68163-541_0623d0fd-931b-4c79-b6ad-47b32a8396e2
• NDC: 68163-541
• Product Type: Human Otc Drug
• Proprietary Name: Nighttime Severe Cold and Cough
• Generic Name: Acetaminophen, Diphenhydramine, Phenylephrine
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-22
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: RARITAN PHARMACEUTICALS INC
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/1; mg/1; mg/1
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68163-541-06

6 PACKET in 1 CARTON (68163-541-06) > 1 POWDER, FOR SOLUTION in 1 PACKET

• Marketing Start Date: 2019-03-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68163-541-06 [68163054106]

Nighttime Severe Cold and Cough POWDER, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-03-22

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/1

OpenFDA Data

• SPL SET ID: 9819155b-2713-42be-867e-16605e7643d0
• Manufacturer:
  • RARITAN PHARMACEUTICALS INC
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• UPC Code:
  • 0368163541069

NDC Crossover Matching brand name "Nighttime Severe Cold and Cough" or generic name "Acetaminophen, Diphenhydramine, Phenylephrine"

NDC	Brand Name	Generic Name
49580-0502	Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
68163-541	Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
59779-876	CVS Health Nighttime Severe Cough and Cold	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
0363-5410	Nighttime Wal Flu Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
63868-291	Quality Choice Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
67091-323	Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE