daytime severe cold and flu (51316-525)

Drug Facts

Product Profile

Brand Name daytime severe cold and flu

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler cvs health corp

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer

CVS HEALTH CORP

Identifiers & Regulatory

Product NDC 51316-525

Product ID 51316-525_2ba90b91-2e36-4701-e063-6294a90a7554

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2025-02-01

Pharmacologic Class

Established (EPC)

expectorant [epc]

Physiologic Effect

decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316525

Hyphenated Format 51316-525

Supplemental Identifiers

RxCUI

1656815

UNII

362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ

NUI

N0000193956 N0000008867 N0000009560

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 severe cold and flu (source: ndc)

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1
200 mg/1
5 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (51316-525-24) / 12 CAPSULE in 1 BLISTER PACK

source: ndc

Packages (1)

51316-525-24 2 BLISTER PACK in 1 CARTON (51316-525-24) / 12 CAPSULE in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

DAYTIME SEVERE COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2ba90b91-2e36-4701-e063-6294a90a7554", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["2ba90b91-2e35-4701-e063-6294a90a7554"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS HEALTH CORP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-525-24)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "51316-525-24", "marketing_start_date": "20250201"}], "brand_name": "DAYTIME SEVERE COLD AND FLU", "product_id": "51316-525_2ba90b91-2e36-4701-e063-6294a90a7554", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "51316-525", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "CVS HEALTH CORP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DAYTIME SEVERE COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}