Over-the-counter drug · OTC MONOGRAPH DRUG
Robitussin Maximum Strength Cough Plus Chest Congestion DM (Dextromethorphan hbr, guaifenesin) NDC 0031-8739
Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL · Solution · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0031-8739Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00031-8739Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-8739-12 | 0003187391200031873912 | 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLEMarketed from Jun 1, 2016 | |
| 0031-8739-18 | 0003187391800031873918 | 1 BOTTLE in 1 CARTON (0031-8739-18) / 237 mL in 1 BOTTLEMarketed from Jun 1, 2016 | |
| 0031-8739-42 | 0003187394200031873942 | 1 BOTTLE in 1 CARTON (0031-8739-42) / 355 mL in 1 BOTTLEMarketed from Jun 1, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Robitussin Maximum Strength Cough Plus Chest Congestion DM
- Generic name (nonproprietary)
- dextromethorphan hbr, guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/20mLGuaifenesin — 400 mg/20mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0031
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0031-8739_4265eb55-7d39-8ba5-e063-6394a90ad0e5SPL ID 4265eb55-7d39-8ba5-e063-6394a90ad0e5SPL set ID f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7RxCUI 1020138UNII 9D2RTI9KYH, 495W7451VQ
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400031873912followed by a unit qualifier and the quantityPackage 00031-8739-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Excerpt only. Read the full label for complete information.
About NDC 0031-8739
- What is NDC 0031-8739?
- 0031-8739 is the product NDC for Robitussin Maximum Strength Cough Plus Chest Congestion DM, Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL solution, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Robitussin Maximum Strength Cough Plus Chest Congestion DM (Dextromethorphan hbr, guaifenesin).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Robitussin Maximum Strength Cough Plus Chest Congestion DM?
- 1 other product NDC are listed under this name. See all Robitussin Maximum Strength Cough Plus Chest Congestion DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Robitussin Maximum Strength Cough Plus Chest Congestion DM products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Robitussin Maximum Strength Cough Plus Chest Congestion DMdextromethorphan hydrobromide and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0031-8719 | 00031-8719-1000031-8719-20 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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