night cold flu cough and allergy

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

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

Drug Facts

Product Profile

Brand Name night cold flu cough and allergy
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Labeler humanwell puracap pharmaceutical (wuhan), ltd.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Identifiers & Regulatory

Product NDC 53345-020
Product ID 53345-020_27c7656a-64e0-d3d3-e063-6394a90a0a72
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-05-29

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 53345020
Hyphenated Format 53345-020

Supplemental Identifiers

RxCUI
1297288
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 night cold flu cough and allergy (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-020-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-020-01 1 BAG in 1 BOX (53345-020-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Night Cold Flu Cough and Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27c7656a-64e0-d3d3-e063-6394a90a0a72", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-020-01)  / 4000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-020-01", "marketing_start_date": "20130529"}], "brand_name": "Night Cold Flu Cough and Allergy", "product_id": "53345-020_27c7656a-64e0-d3d3-e063-6394a90a0a72", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "53345-020", "generic_name": "acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Night Cold Flu Cough and Allergy", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130529", "listing_expiration_date": "20261231"}