NDC 45014-154

Nite Time Cold and Cough

Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride

Nite Time Cold and Cough is a Oral Liquid 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: 45014-154_2d46d37d-abad-4b65-a19c-69d843ea6662
• NDC: 45014-154
• Product Type: Human Otc Drug
• Proprietary Name: Nite Time Cold and Cough
• Generic Name: Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2009-11-25
• 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 45014-154-04

118 mL in 1 BOTTLE (45014-154-04)

• Marketing Start Date: 2009-11-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45014-154-04 [45014015404]

Nite Time Cold and Cough LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-11-25
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: 64dd0b21-21c5-4d45-ac7f-9896c2a033b0
• 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