severe cold and cough nighttime

Generic: acetaminophen, diphenhydramine, phenylephrine

Labeler: winco foods, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe cold and cough nighttime
Generic Name acetaminophen, diphenhydramine, phenylephrine
Labeler winco foods, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, diphenhydramine hydrochloride 25 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
WinCo Foods, LLC

Identifiers & Regulatory

Product NDC 67091-323
Product ID 67091-323_44f5ddb0-0b8c-0cb8-e063-6294a90a2f26
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

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 67091323
Hyphenated Format 67091-323

Supplemental Identifiers

RxCUI
1659960
UNII
362O9ITL9D 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 severe cold and cough nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine, phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 25 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 6 PACKET in 1 CARTON (67091-323-06) / 1 POWDER, FOR SOLUTION in 1 PACKET
source: ndc

Packages (1)

67091-323-06 6 PACKET in 1 CARTON (67091-323-06) / 1 POWDER, FOR SOLUTION in 1 PACKET

Ingredients (3)

acetaminophen (650 mg/1) diphenhydramine hydrochloride (25 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Severe Cold and Cough Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44f5ddb0-0b8c-0cb8-e063-6294a90a2f26", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1659960"], "spl_set_id": ["dc56197c-c108-4b35-b791-dde5c3384ddd"], "manufacturer_name": ["WinCo Foods, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (67091-323-06)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "67091-323-06", "marketing_start_date": "20180801"}], "brand_name": "Severe Cold and Cough Nighttime", "product_id": "67091-323_44f5ddb0-0b8c-0cb8-e063-6294a90a2f26", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "67091-323", "generic_name": "ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE", "labeler_name": "WinCo Foods, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold and Cough Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}