dimetapp nighttime cold and congestion

Generic: diphenhydramine hydrochloride and phenylephrine hydrochloride

Labeler: foundation consumer brands
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dimetapp nighttime cold and congestion
Generic Name diphenhydramine hydrochloride and phenylephrine hydrochloride
Labeler foundation consumer brands
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 6.25 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Foundation Consumer Brands

Identifiers & Regulatory

Product NDC 80070-340
Product ID 80070-340_4b837950-3c27-be85-e063-6294a90ab6b6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-09-15
Marketing End 2026-12-31

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 80070340
Hyphenated Format 80070-340

Supplemental Identifiers

RxCUI
1236048
UPC
0850026660043
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 dimetapp nighttime cold and congestion (source: ndc)
Generic Name diphenhydramine hydrochloride and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

80070-340-04 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (6.25 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Dimetapp Nighttime Cold and Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b837950-3c27-be85-e063-6294a90ab6b6", "openfda": {"upc": ["0850026660043"], "unii": ["TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1236048"], "spl_set_id": ["96a1055f-e831-4f4b-8af3-7a41838c194c"], "manufacturer_name": ["Foundation Consumer Brands"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (80070-340-04)  / 118 mL in 1 BOTTLE", "package_ndc": "80070-340-04", "marketing_end_date": "20261231", "marketing_start_date": "20210915"}], "brand_name": "Dimetapp Nighttime Cold and Congestion", "product_id": "80070-340_4b837950-3c27-be85-e063-6294a90ab6b6", "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": "80070-340", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Foundation Consumer Brands", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetapp", "brand_name_suffix": "Nighttime Cold and Congestion", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261231", "marketing_start_date": "20210915"}