childrens benadryl allergy plus congestion

Generic: diphenhydramine hydrochloride and phenylephrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens benadryl allergy plus congestion
Generic Name diphenhydramine hydrochloride and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-341
Product ID 50580-341_21e89245-b2fa-5dd2-e063-6294a90a7795
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-09-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580341
Hyphenated Format 50580-341

Supplemental Identifiers

RxCUI
1086720 1086723
UPC
0300450170057
UNII
TC2D6JAD40 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens benadryl allergy plus congestion (source: ndc)
Generic Name diphenhydramine hydrochloride and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-341-01) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (2)

diphenhydramine hydrochloride (12.5 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Childrens Benadryl Allergy Plus Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21e89245-b2fa-5dd2-e063-6294a90a7795", "openfda": {"upc": ["0300450170057"], "unii": ["TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1086720", "1086723"], "spl_set_id": ["b8b75904-3806-4258-89c1-d6ff486ed41c"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-341-01)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-341-01", "marketing_start_date": "20140930"}], "brand_name": "Childrens Benadryl Allergy Plus Congestion", "product_id": "50580-341_21e89245-b2fa-5dd2-e063-6294a90a7795", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50580-341", "generic_name": "Diphenhydramine hydrochloride and Phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Benadryl Allergy Plus Congestion", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140930", "listing_expiration_date": "20261231"}