NDC 45014-159

Nite Time Cold and Cough

Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride

Nite Time Cold and Cough is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Accudial Pharmaceutical, Inc.. The primary component is Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 45014-159_9eaf18d1-da77-46e4-9730-3671f8529fb6
• NDC: 45014-159
• Product Type: Human Otc Drug
• Proprietary Name: Nite Time Cold and Cough
• Generic Name: Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Accudial Pharmaceutical, Inc.
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 6 mg/5mL; mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 45014-159-04

118 mL in 1 BOTTLE (45014-159-04)

• Marketing Start Date: 2013-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45014-159-04 [45014015904]

Nite Time Cold and Cough SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: b41f9c5b-8671-43f0-acd1-1b21051246ec
• Manufacturer:
  • Accudial Pharmaceutical, Inc.
• UNII:
  • TC2D6JAD40
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1236048

NDC Crossover Matching brand name "Nite Time Cold and Cough" or generic name "Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
30142-021	nite time cold and cough	Diphenhydramine HCl, Phenylephrine HCl
45014-154	Nite Time Cold and Cough	Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride
45014-159	Nite Time Cold and Cough	Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride
50580-415	Benadryl Allergy Plus Congestion	Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride
50580-341	Childrens Benadryl Allergy Plus Congestion	Diphenhydramine hydrochloride and Phenylephrine hydrochloride
80070-340	Dimetapp	DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE
50580-736	SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION	Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride
50580-239	SUDAFED PE SINUS CONGESTION	diphenhydramine hydrochloride and phenylephrine hydrochloride