NDC product

Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr

NDC 35916-0166 · Softgel Healthcare Pvt Ltd

Key facts

Product NDC 35916-0166
Proprietary name Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
Substances PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, GUAIFENESIN
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 Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA] and 3 more
Marketing start Oct 29, 2024
Listing certified through Dec 31, 2027

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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