NDC product

Acetaminophen, Dextromethorphan HBr,Guaifenesin

NDC 35916-0184 · Softgel Healthcare Pvt Ltd

Key facts

Product NDC 35916-0184
Proprietary name Acetaminophen, Dextromethorphan HBr ,Guaifenesin
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin
Substances GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Product type HUMAN OTC DRUG
Marketing category OTC MONOGRAPH DRUG
Application number M012
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] and 1 more
Marketing start May 17, 2025
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

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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