severe cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Labeler cvs woonsocket prescription center, incorporated
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, doxylamine succinate 6.25 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-533
Product ID 51316-533_4fb8b402-7652-45b9-a458-53102fc5f5d0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-26

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] antihistamine [epc] histamine receptor antagonists [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 51316533
Hyphenated Format 51316-533

Supplemental Identifiers

RxCUI
1431245
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 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 flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 6.25 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE (51316-533-40)
source: ndc

Packages (1)

51316-533-40 355 mL in 1 BOTTLE (51316-533-40)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) doxylamine succinate (6.25 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

SEVERE COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4fb8b402-7652-45b9-a458-53102fc5f5d0", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["0d97c634-0975-42d5-8ade-2ed2018cfe9d"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (51316-533-40)", "package_ndc": "51316-533-40", "marketing_start_date": "20260126"}], "brand_name": "SEVERE COLD AND FLU", "product_id": "51316-533_4fb8b402-7652-45b9-a458-53102fc5f5d0", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [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": "51316-533", "generic_name": "acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SEVERE COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260126", "listing_expiration_date": "20271231"}