cough and cold plus

Generic: acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr

Labeler: humanwell puracap pharmaceutical (wuhan) co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cough and cold plus
Generic Name acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr
Labeler humanwell puracap pharmaceutical (wuhan) co., ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

Identifiers & Regulatory

Product NDC 53345-045
Product ID 53345-045_27c7a311-d24c-3a6e-e063-6394a90a5902
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-03-24

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 53345045
Hyphenated Format 53345-045

Supplemental Identifiers

RxCUI
1042688
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 cough and cold plus (source: ndc)
Generic Name acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 2 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-045-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-045-01 1 BAG in 1 BOX (53345-045-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

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)

Cough and Cold plus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27c7a311-d24c-3a6e-e063-6394a90a5902", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1042688"], "spl_set_id": ["c483d88f-cb0a-4dd6-b3ae-559521782ba6"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-045-01)  / 4000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-045-01", "marketing_start_date": "20170324"}], "brand_name": "Cough and Cold plus", "product_id": "53345-045_27c7a311-d24c-3a6e-e063-6394a90a5902", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "53345-045", "generic_name": "Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough and Cold plus", "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": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170324", "listing_expiration_date": "20261231"}