Over-the-counter drug · OTC MONOGRAPH DRUG
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NDC 0031-0100
acetaminophen, dextromethorphan hydrobromide, guaifenesin · Acetaminophen 650 mg/20mL + 2 more ingredients · Liquid · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0031-0100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00031-0100Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-0100-04 | 00031010004 | 1 BOTTLE in 1 CARTON (0031-0100-04) / 118 mL in 1 BOTTLEMarketed from Feb 15, 2024 | |
| 0031-0100-08 | 00031010008 | 1 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLEMarketed from Feb 15, 2024 |
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 Severe Multi-Symptom Cough Cold Flu
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, guaifenesin
- Active ingredients
- Acetaminophen — 650 mg/20mLDextromethorphan hydrobromide — 20 mg/20mLGuaifenesin — 400 mg/20mL
- Dosage form
- Liquid
- 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 0031-0100_43e64251-a916-1cb7-e063-6294a90a393aSPL ID 43e64251-a916-1cb7-e063-6294a90a393aSPL set ID a6f750c8-8738-4965-a3ad-612c24611056RxCUI 2680300UNII 362O9ITL9D, 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
N400031010004followed by a unit qualifier and the quantityPackage 00031-0100-04. 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 these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Excerpt only. Read the full label for complete information.
About NDC 0031-0100
- What is NDC 0031-0100?
- 0031-0100 is the product NDC for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu, Acetaminophen 650 mg/20mL + 2 more ingredients liquid, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu (Acetaminophen, dextromethorphan hydrobromide, guaifenesin).
- What is the active ingredient?
- Acetaminophen, 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 Severe Multi-Symptom Cough Cold Flu?
- 1 other product NDC are listed under this name. See all Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 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 Severe Multi-Symptom Cough Cold Flu 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 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 | 00031-0101-04 |
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 |
|---|---|---|---|---|
| equate allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-297 |
| Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Doxylamine succinate 12.5 mg/30mL + 3 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-775 |
| Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Belmora LLC | 27854-299 |
| Allergy Reliefdiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9285 |
| Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl | — | Kit | Kroger Company | 30142-616 |
| nasal decongestantoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | A-S Medication Solutions | 50090-5281 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola Ag | 54305-342 |
| Geri-Tussin DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-661 |
| Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL | LiquidOral | FAMILY DOLLAR SERVICES INC | 55319-754 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-925 |
| Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | Gil Pharmaceutical Corp | 58552-332 |
| Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate | — | Kit | Haleon US Holdings LLC | 0031-2099 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0505 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 63824-956 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | NuCare Pharmaceuticals, Inc. | 68071-3858 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1799 |
| nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-2029 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | BIONPHARMA INC. | 69452-445 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
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