severe cold and cough daytime

Generic: acetaminohpen, dextromethorphan hbr, phenylephrine hcl

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe cold and cough daytime
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl
Labeler top care (topco associates llc)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-316
Product ID 36800-316_a27f25fd-eb27-4a01-bf6a-bc5eb0a288e5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-11-30

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 36800316
Hyphenated Format 36800-316

Supplemental Identifiers

RxCUI
1113705
UPC
0036800224490
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 severe cold and cough daytime (source: ndc)
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 245 mL in 1 BOTTLE, PLASTIC (36800-316-08)
source: ndc

Packages (1)

36800-316-08 245 mL in 1 BOTTLE, PLASTIC (36800-316-08)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Severe Cold and Cough Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a27f25fd-eb27-4a01-bf6a-bc5eb0a288e5", "openfda": {"upc": ["0036800224490"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["c6475e58-5152-4dad-be2f-4ca32b8589d7"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245 mL in 1 BOTTLE, PLASTIC (36800-316-08)", "package_ndc": "36800-316-08", "marketing_start_date": "20151130"}], "brand_name": "Severe Cold and Cough Daytime", "product_id": "36800-316_a27f25fd-eb27-4a01-bf6a-bc5eb0a288e5", "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": "36800-316", "generic_name": "ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold and Cough", "brand_name_suffix": "Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20151130", "listing_expiration_date": "20261231"}