daytime cold and flu

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Labeler: cvs woonsocket prescription center, incorporated
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 cvs woonsocket prescription center, incorporated
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-350
Product ID 51316-350_8dbc2671-20b4-49f0-9b98-ccf19cec57ed
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-14

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 51316350
Hyphenated Format 51316-350

Supplemental Identifiers

RxCUI
1113705
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
  • 1 BOTTLE in 1 CARTON (51316-350-34) / 237 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51316-350-40) / 355 mL in 1 BOTTLE
source: ndc

Packages (2)

51316-350-34 1 BOTTLE in 1 CARTON (51316-350-34) / 237 mL in 1 BOTTLE 51316-350-40 1 BOTTLE in 1 CARTON (51316-350-40) / 355 mL in 1 BOTTLE

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": "8dbc2671-20b4-49f0-9b98-ccf19cec57ed", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["ecf7d210-102c-4053-81f6-67116de6cf7b"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-350-34)  / 237 mL in 1 BOTTLE", "package_ndc": "51316-350-34", "marketing_start_date": "20260114"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-350-40)  / 355 mL in 1 BOTTLE", "package_ndc": "51316-350-40", "marketing_start_date": "20260122"}], "brand_name": "daytime cold and flu", "product_id": "51316-350_8dbc2671-20b4-49f0-9b98-ccf19cec57ed", "dosage_form": "SOLUTION", "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": "51316-350", "generic_name": "acetaminophen, dextromethorphan Hbr, Phenylephrine HCl", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "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": "20260114", "listing_expiration_date": "20271231"}