cold multi-symptom night-time

Generic: acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold multi-symptom night-time
Generic Name acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, chlorpheniramine maleate 2 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-319
Product ID 69168-319_2c10d41f-cfbb-48dc-851f-b2959d12e075
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2014-12-23

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] 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 69168319
Hyphenated Format 69168-319

Supplemental Identifiers

RxCUI
1086991
UNII
362O9ITL9D V1Q0O9OJ9Z 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 cold multi-symptom night-time (source: ndc)
Generic Name acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 2 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BLISTER PACK (69168-319-86)
source: ndc

Packages (1)

69168-319-86 12 TABLET in 1 BLISTER PACK (69168-319-86)

Ingredients (4)

acetaminophen (325 mg/1) chlorpheniramine maleate (2 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cold Multi-Symptom Night-time ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c10d41f-cfbb-48dc-851f-b2959d12e075", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086991"], "spl_set_id": ["3f020cf2-6011-4216-9b39-0b3dc5f0749c"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BLISTER PACK (69168-319-86)", "package_ndc": "69168-319-86", "marketing_start_date": "20141223"}], "brand_name": "Cold Multi-Symptom Night-time", "product_id": "69168-319_2c10d41f-cfbb-48dc-851f-b2959d12e075", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "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": "69168-319", "generic_name": "Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Multi-Symptom", "brand_name_suffix": "Night-time", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141223", "listing_expiration_date": "20261231"}