NDC 50580-341

Childrens Benadryl Allergy Plus Congestion

Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride

Childrens Benadryl Allergy Plus Congestion is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 50580-341_29413e08-1dfb-49b5-b9fd-459ef1baa2c8
• NDC: 50580-341
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Benadryl Allergy Plus Congestion
• Generic Name: Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50580-341-01

1 BOTTLE in 1 CARTON (50580-341-01) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2014-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-341-01 [50580034101]

Childrens Benadryl Allergy Plus Congestion SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-09-30

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

OpenFDA Data

• SPL SET ID: b8b75904-3806-4258-89c1-d6ff486ed41c
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • TC2D6JAD40
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1086720
  • 1086723

NDC Crossover Matching brand name "Childrens Benadryl Allergy Plus Congestion" or generic name "Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride"

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