Over-the-counter drug · OTC MONOGRAPH DRUG
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM NDC 0031-8759
dextromethorphan hydrobromide, guaifenesin · Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL · Solution · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-8759-12 | 0003187591200031875912 | 1 BOTTLE in 1 CARTON (0031-8759-12) / 118 mL in 1 BOTTLEMarketed from Feb 16, 2018 |
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 Sugar-Free Dye-Free Cough Plus Chest Congestion DM
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/20mLGuaifenesin — 200 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 0031-8759_e4426213-924d-481d-a712-9dbf7875eafdSPL ID e4426213-924d-481d-a712-9dbf7875eafdSPL set ID 036162c9-f5a6-418e-bd5e-ebd72097d27dRxCUI 1790650UNII 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
N400031875912followed by a unit qualifier and the quantityPackage 00031-8759-12. 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 0031-8759
- What is NDC 0031-8759?
- 0031-8759 is the product NDC for Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM, Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL solution, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM (Dextromethorphan hydrobromide, 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 Sugar-Free Dye-Free Cough Plus Chest Congestion DM?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| MGC Health Cough Drops Honey Herbmenthol | Menthol 4.8 mg/1 | LozengeOral | Medical Group Care LLC | 83173-133 |
| Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | RITE AID | 11822-1987 |
| daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Kroger Company | 30142-603 |
| TopCare Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-367 |
| Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride | Dextromethorphan hydrobromide 10 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-693 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FOODHOLD U.S.A., LLC | 41520-290 |
| good sense tussin dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | SolutionOral | A-S Medication Solutions | 50090-7257 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Cough Dropsmenthol | Menthol 7.5 mg/1 | PastilleOral | The Kroger CO | 59450-716 |
| Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-244 |
| Childrens Allergy Relief | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Allegiant Health | 69168-471 |
| Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate | — | Kit | CVS Pharmacy,Inc. | 69842-546 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0161 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-035 |
| Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hcl | Triprolidine hydrochloride 1.25 mg/10mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 72854-063 |
| Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mg | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | Ulai Health LLC | 73057-381 |
| MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride | — | Kit | Topco Associates LLC | 76162-679 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate | — | KitOral | BETTER LIVING BRANDS, LLC | 21130-967 |
| Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl | — | Kit | KROGER COMPANY | 41226-678 |
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