cold and flu nighttime

Generic: acetaminophen, dextromethorphan hbr, triprolidine hcl

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

Drug Facts

Product Profile

Brand Name cold and flu nighttime
Generic Name acetaminophen, dextromethorphan hbr, triprolidine hcl
Labeler cvs woonsocket prescription center, incorporated
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, triprolidine hydrochloride 2.5 mg/20mL

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-963
Product ID 51316-963_bdeed55a-f6e6-4881-b352-16003f1a3fac
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-10-23

Pharmacologic Class

Classes
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316963
Hyphenated Format 51316-963

Supplemental Identifiers

RxCUI
2173667
UNII
362O9ITL9D 9D2RTI9KYH YAN7R5L890

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 cold and flu nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, triprolidine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
  • 2.5 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (51316-963-45)
source: ndc

Packages (1)

51316-963-45 177 mL in 1 BOTTLE, PLASTIC (51316-963-45)

Ingredients (3)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) triprolidine hydrochloride (2.5 mg/20mL)

Linked Drug Pages (1)

Cold and Flu Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bdeed55a-f6e6-4881-b352-16003f1a3fac", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "YAN7R5L890"], "rxcui": ["2173667"], "spl_set_id": ["0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (51316-963-45)", "package_ndc": "51316-963-45", "marketing_start_date": "20231023"}], "brand_name": "Cold and Flu Nighttime", "product_id": "51316-963_bdeed55a-f6e6-4881-b352-16003f1a3fac", "dosage_form": "SOLUTION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "51316-963", "generic_name": "Acetaminophen, Dextromethorphan HBr, Triprolidine HCl", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu", "brand_name_suffix": "Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "TRIPROLIDINE HYDROCHLORIDE", "strength": "2.5 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231023", "listing_expiration_date": "20261231"}