cold multi-symptom

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name cold multi-symptom
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler allegiant health
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-324
Product ID 69168-324_b31c44ba-30a7-4731-8169-2a3f2a5de4d5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2015-08-15

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 69168324
Hyphenated Format 69168-324

Supplemental Identifiers

RxCUI
1094538
UPC
0369168324862
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 cold multi-symptom (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69168-324-86) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

69168-324-86 1 BLISTER PACK in 1 CARTON (69168-324-86) / 12 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Cold Multi-Symptom ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b31c44ba-30a7-4731-8169-2a3f2a5de4d5", "openfda": {"upc": ["0369168324862"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1094538"], "spl_set_id": ["9a4c0c43-a71a-4e22-a3d5-9eb9622689a2"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69168-324-86)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "69168-324-86", "marketing_start_date": "20150815"}], "brand_name": "Cold Multi-Symptom", "product_id": "69168-324_b31c44ba-30a7-4731-8169-2a3f2a5de4d5", "dosage_form": "TABLET, COATED", "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": "69168-324", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Multi-Symptom", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 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": "20150815", "listing_expiration_date": "20261231"}