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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