topcare day time cold and flu (76162-500)

Drug Facts

Product Profile

Brand Name topcare day time cold and flu

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler topco associates llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, guaifenesin 200 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-500

Product ID 76162-500_012e7952-f166-440e-b8db-0a2364f79e72

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2023-06-30

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 76162500

Hyphenated Format 76162-500

Supplemental Identifiers

RxCUI

1369842

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 topcare day time cold and flu (source: ndc)

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/15mL
10 mg/15mL
200 mg/15mL
5 mg/15mL

source: ndc

Packaging

355 mL in 1 BOTTLE (76162-500-40)

source: ndc

Packages (1)

76162-500-40 355 mL in 1 BOTTLE (76162-500-40)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) guaifenesin (200 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

topcare day time cold and flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "012e7952-f166-440e-b8db-0a2364f79e72", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["256d96f0-67bf-42d2-85ef-f49625c5910f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (76162-500-40)", "package_ndc": "76162-500-40", "marketing_start_date": "20230630"}], "brand_name": "topcare day time cold and flu", "product_id": "76162-500_012e7952-f166-440e-b8db-0a2364f79e72", "dosage_form": "SOLUTION", "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": "76162-500", "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare day time cold and flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}