NDC 67091-323

Severe Cold and Cough Nighttime

Acetaminophen, Diphenhydramine, Phenylephrine

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

• Product ID: 67091-323_7d323074-1e20-4edb-8b6e-dd4bcc7e8658
• NDC: 67091-323
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Cough Nighttime
• Generic Name: Acetaminophen, Diphenhydramine, Phenylephrine
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: WinCo Foods, LLC
• 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 67091-323-06

6 PACKET in 1 CARTON (67091-323-06) > 1 POWDER, FOR SOLUTION in 1 PACKET

• Marketing Start Date: 2018-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67091-323-06 [67091032306]

Severe Cold and Cough Nighttime POWDER, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/1

OpenFDA Data

• SPL SET ID: dc56197c-c108-4b35-b791-dde5c3384ddd
• Manufacturer:
  • WinCo Foods, LLC
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1659960

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

NDC	Brand Name	Generic Name
67091-323	Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
55319-602	Severe Cold and Cough Nighttime	Severe Cold and Cough Nighttime
59779-876	CVS Health Nighttime Severe Cough and Cold	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
68163-541	Nighttime Severe Cold and Cough	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