cold and congestion childrens nighttime

Generic: diphenhydramine hci, phenylephrine hcl

Labeler: walgreens
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and congestion childrens nighttime
Generic Name diphenhydramine hci, phenylephrine hcl
Labeler walgreens
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-0058
Product ID 0363-0058_7febd3a1-07d3-4499-bd13-0b876e1c20f8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-03-31

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 03630058
Hyphenated Format 0363-0058

Supplemental Identifiers

RxCUI
1236048
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 cold and congestion childrens nighttime (source: ndc)
Generic Name diphenhydramine hci, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (0363-0058-04)
source: ndc

Packages (1)

0363-0058-04 118 mL in 1 BOTTLE, PLASTIC (0363-0058-04)

Ingredients (2)

diphenhydramine hydrochloride (12.5 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Cold and Congestion Childrens Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7febd3a1-07d3-4499-bd13-0b876e1c20f8", "openfda": {"unii": ["TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1236048"], "spl_set_id": ["a7847413-e556-4f88-8a7f-a8528afbe927"], "manufacturer_name": ["Walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0363-0058-04)", "package_ndc": "0363-0058-04", "marketing_start_date": "20160331"}], "brand_name": "Cold and Congestion Childrens Nighttime", "product_id": "0363-0058_7febd3a1-07d3-4499-bd13-0b876e1c20f8", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0363-0058", "generic_name": "Diphenhydramine HCI, Phenylephrine HCl", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Congestion", "brand_name_suffix": "Childrens Nighttime", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160331", "listing_expiration_date": "20261231"}