NDC 50580-415

Benadryl Allergy Plus Congestion

Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride

Benadryl Allergy Plus Congestion is a Oral Tablet, Film Coated 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 ID50580-415_6ed0bfe8-c0e1-40d3-9395-1f6ec7c3f6e6
NDC50580-415
Product TypeHuman Otc Drug
Proprietary NameBenadryl Allergy Plus Congestion
Generic NameDiphenhydramine Hydrochloride And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-06-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50580-415-01

2 BLISTER PACK in 1 CARTON (50580-415-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2017-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-415-01 [50580041501]

Benadryl Allergy Plus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-19

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:685b51d3-cc25-47b2-ac8a-368924f43137
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1926221
  • 1052928
  • UPC Code
  • 0300450557261
  • NDC Crossover Matching brand name "Benadryl Allergy Plus Congestion" or generic name "Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-415Benadryl Allergy Plus CongestionDiphenhydramine Hydrochloride and Phenylephrine Hydrochloride
    50580-341Childrens Benadryl Allergy Plus CongestionDiphenhydramine hydrochloride and Phenylephrine hydrochloride
    80070-340DimetappDIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE
    45014-154Nite Time Cold and CoughDiphenhydramine Hydrochloride and Phenylephrine Hydrochloride
    45014-159Nite Time Cold and CoughDiphenhydramine Hydrochloride and Phenylephrine Hydrochloride
    50580-736SUDAFED PE DAY PLUS NIGHT SINUS CONGESTIONDiphenhydramine Hydrochloride and Phenylephrine Hydrochloride
    50580-239SUDAFED PE SINUS CONGESTIONdiphenhydramine hydrochloride and phenylephrine hydrochloride

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