NDC product

Childrens Robitussin 12 Hour Cough Relief

NDC 0031-8725 · Haleon US Holdings LLC

Key facts

Product NDC 0031-8725
Proprietary name Childrens Robitussin 12 Hour Cough Relief
Nonproprietary name dextromethorphan polistirex
Substances DEXTROMETHORPHAN HYDROBROMIDE
Dosage form SUSPENSION, EXTENDED RELEASE
Route ORAL
Labeler Haleon US Holdings LLC
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA091135
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
Marketing start Jul 5, 2016
Listing certified through Dec 31, 2026

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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