NDC product

Night Cold Flu Cough and Allergy

NDC 53345-020 · Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Key facts

Product NDC 53345-020
Proprietary name Night Cold Flu Cough and Allergy
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Substances ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Product type HUMAN OTC DRUG
Marketing category OTC MONOGRAPH DRUG
Application number M012
Pharmacologic 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] and 2 more
Marketing start May 29, 2013
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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