United States · FDA National Drug Code directory

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef
Product NDC
0031-8765
Form
TABLET, EXTENDED RELEASE
Composition / generic term
Dextromethorphan Hydrobromide, Guaifenesin
Labeler
Haleon US Holdings LLC
Marketing category
ANDA
Marketing start / end (source format)
20190614
Source listing expiry
20261231

Source-listed ingredients

  • DEXTROMETHORPHAN HYDROBROMIDE — 60 mg/1
  • GUAIFENESIN — 1200 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK · 0031-8765-04
  • 1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK · 0031-8765-08
  • 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK · 0031-8765-16

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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