daytime cold and flu

Generic: acetaminophen dextromethorphan hbr phenylephrine hcl

Labeler: quality choice (chain drug marketing association)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime cold and flu
Generic Name acetaminophen dextromethorphan hbr phenylephrine hcl
Labeler quality choice (chain drug marketing association)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)

Identifiers & Regulatory

Product NDC 83324-167
Product ID 83324-167_5a586e44-70db-4b17-9ae1-4b9bb77d9fa4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83324167
Hyphenated Format 83324-167

Supplemental Identifiers

RxCUI
1113705
UPC
0635515970205
UNII
362O9ITL9D 9D2RTI9KYH 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 daytime cold and flu (source: ndc)
Generic Name acetaminophen dextromethorphan hbr phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE, PLASTIC (83324-167-12)
source: ndc

Packages (1)

83324-167-12 355 mL in 1 BOTTLE, PLASTIC (83324-167-12)

Ingredients (3)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

Daytime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5a586e44-70db-4b17-9ae1-4b9bb77d9fa4", "openfda": {"upc": ["0635515970205"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["4754363d-e163-42e0-a65d-1c4bac24f6c9"], "manufacturer_name": ["QUALITY CHOICE (Chain Drug Marketing Association)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (83324-167-12)", "package_ndc": "83324-167-12", "marketing_start_date": "20240731"}], "brand_name": "Daytime Cold and Flu", "product_id": "83324-167_5a586e44-70db-4b17-9ae1-4b9bb77d9fa4", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "83324-167", "generic_name": "Acetaminophen Dextromethorphan HBr Phenylephrine HCl", "labeler_name": "QUALITY CHOICE (Chain Drug Marketing Association)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240731", "listing_expiration_date": "20261231"}