cvs nighttime cold

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

Labeler: cvs pharmacy
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cvs nighttime cold
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Labeler cvs pharmacy
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, doxylamine succinate 12.5 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
CVS PHARMACY

Identifiers & Regulatory

Product NDC 51316-641
Product ID 51316-641_456f8608-317d-67a8-e063-6294a90a4439
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

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 51316641
Hyphenated Format 51316-641

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 cvs nighttime cold (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 12.5 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 354 mL in 1 BOTTLE, PLASTIC (51316-641-12)
source: ndc

Packages (1)

51316-641-12 354 mL in 1 BOTTLE, PLASTIC (51316-641-12)

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) doxylamine succinate (12.5 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

CVS NightTime Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "456f8608-317d-67a8-e063-6294a90a4439", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["0f0cc40d-7939-4d4d-a931-b4de4070fea1"], "manufacturer_name": ["CVS PHARMACY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "354 mL in 1 BOTTLE, PLASTIC (51316-641-12)", "package_ndc": "51316-641-12", "marketing_start_date": "20230109"}], "brand_name": "CVS NightTime Cold", "product_id": "51316-641_456f8608-317d-67a8-e063-6294a90a4439", "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": "51316-641", "generic_name": "acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride", "labeler_name": "CVS PHARMACY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CVS NightTime Cold", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}