Data / Drug companies / Haleon US Holdings LLC
Haleon US Holdings LLC: 47 products in the FDA NDC directory, labeler code 0031
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Haleon US Holdings LLC (labeler code 0031) lists 47 products in the FDA National Drug Code Directory, covering 17 finished drugs by generic name. By type: 45 over the counter drugs, 1 drugs for further processing. Its main marketing category is over the counter monograph drugs. The newest product started marketing on August 21, 2026.
The request: Watch Haleon US Holdings LLC (FDA labeler code 0031): each new product listing and each discontinued product. $10 of work on sign-up, no card.
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- Labeler code
- 0031
- Products in commercial distribution
- 47
- Packages
- 67
- Finished drugs by generic name
- 17
- Prescription products
- 0
- Over the counter products
- 45
- Flagged as original packager
- 45 of 45 products that carry the flag
- Started marketing in the last 12 months
- 1
- Earliest marketing start
- January 1, 2004
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Over the counter monograph drugs | 38 | 80.9% |
| Generic drugs (ANDA) | 7 | 14.9% |
| Drugs for further processing | 1 | 2.1% |
| Export only | 1 | 2.1% |
Products by type
| Type | Products | Share |
|---|---|---|
| Over the counter drugs | 45 | 95.7% |
| Drugs for further processing | 1 | 2.1% |
| Bulk ingredients | 1 | 2.1% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Dextromethorphan polistirex | 6 | 27 |
| Dextromethorphan hbr, guaifenesin | 5 | 67 |
| Dextromethorphan hydrobromide | 4 | 17 |
| Dextromethorphan hydrobromide, guaifenesin | 3 | 49 |
| Dextromethorphan hydrobromide and guaifenesin | 3 | 16 |
| Dextromethorphan hydrobromide, doxylamine succinate | 2 | 9 |
| Dextromethorphan hydrobromide, menthol | 2 | 1 |
| Dextromethorphan hbr, doxylamine succinate | 2 | 12 |
| Dextromethorphan hbr, guaifenesin, doxylamine succinate | 2 | 1 |
| Acetaminophen, dextromethorphan hbr | 1 | 20 |
| Chlorpheniramine maleate, dextrometrorphan hbr | 1 | 3 |
| Acetaminophen, dextromethorphan hydrobromide | 1 | 20 |
| Acetaminophen and diphenhydramine hydrochloride | 1 | 29 |
| Acetaminophen, dextromethorphan hydrobromide, guaifenesin | 1 | 7 |
| Acetaminophen, diphenhydramine hcl | 1 | 42 |
| Acetaminophen | 1 | 214 |
| Chlorpheniramine maleate, dextromethorphan hydrobromide | 1 | 2 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 14 | 29.8% |
| Liquid | 10 | 21.3% |
| Suspension, extended release | 6 | 12.8% |
| Kit | 5 | 10.6% |
| Capsule, liquid filled | 4 | 8.5% |
| Lozenge | 2 | 4.3% |
| Syrup | 2 | 4.3% |
| Tablet, chewable | 2 | 4.3% |
| Tablet, extended release | 1 | 2.1% |
| Tablet, coated | 1 | 2.1% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Sigma-1 Agonist | 36 |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist | 36 |
| Expectorant | 15 |
| Antihistamine | 5 |
| Histamine-1 Receptor Antagonist | 5 |
| alpha-1 Adrenergic Agonist | 4 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Acetaminophen, dextromethorphan hbr, doxylamine succinate | 0031-8989 | Syrup | Drugs for further processing | August 21, 2026 |
| ROBITUSSIN Nighttime Cough DM Soft CHEWS | 0031-9311 | Tablet, chewable | Over the counter monograph drugs | June 19, 2024 |
| ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | 0031-9310 | Tablet, chewable | Over the counter monograph drugs | June 19, 2024 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | 0031-0101 | Liquid | Over the counter monograph drugs | February 15, 2024 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | 0031-0100 | Liquid | Over the counter monograph drugs | February 15, 2024 |
| Robitussin Medi-Soothers | 0031-9307 | Lozenge | Over the counter monograph drugs | June 1, 2023 |
| Robitussin Medi-Soothers | 0031-9306 | Lozenge | Over the counter monograph drugs | June 1, 2023 |
| Robitussin Direct Cough | 0031-9302 | Capsule, liquid filled | Over the counter monograph drugs | July 15, 2022 |
| Robitussin Direct Sore Throat Pain | 0031-9301 | Tablet, coated | Over the counter monograph drugs | July 15, 2022 |
| Childrens Robitussin Elderberry Cough and Chest Congestion DM | 0031-2098 | Solution | Over the counter monograph drugs | June 14, 2021 |
| Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM | 0031-2097 | Solution | Over the counter monograph drugs | June 14, 2021 |
| Robitussin Day and Night Cough Relief DM Max | 0031-2834 | Kit | Over the counter monograph drugs | March 1, 2021 |
| Robitussin Day and Night Maximum Strength Cough DM | 0031-2103 | Kit | Over the counter monograph drugs | March 1, 2021 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat | 0031-8771 | Solution | Over the counter monograph drugs | June 15, 2020 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime | 0031-8770 | Solution | Over the counter monograph drugs | June 15, 2020 |
| Childrens Robitussin Cough and Chest Congestion DM | 0031-8702 | Liquid | Over the counter monograph drugs | May 12, 2020 |
| Robitussin Day and Night Cough Relief Value Pack | 0031-2099 | Kit | Over the counter monograph drugs | May 12, 2020 |
| Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 0031-8765 | Tablet, extended release | Generic drugs (ANDA) | June 14, 2019 |
| Childrens Robitussin Honey Nighttime Cough DM | 0031-8762 | Solution | Over the counter monograph drugs | May 27, 2019 |
| Robitussin Childrens Honey Day Night DM Value Pack | 0031-2102 | Kit | Over the counter monograph drugs | May 27, 2019 |
| Robitussin Honey Cough DM Day Night Value Pack | 0031-2059 | Kit | Over the counter monograph drugs | April 30, 2019 |
| Robitussin long-acting coughgels | 0031-8743 | Capsule, liquid filled | Over the counter monograph drugs | January 4, 2019 |
| Childrens Robitussin Honey Cough and Chest Congestion DM | 0031-8760 | Solution | Over the counter monograph drugs | June 25, 2018 |
| Robitussin Honey Maximum Strength Nighttime Cough DM | 0031-8758 | Solution | Over the counter monograph drugs | June 25, 2018 |
| Robitussin Honey Maximum Strength Cough and Chest Congestion DM | 0031-8756 | Solution | Over the counter monograph drugs | June 25, 2018 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.