Robitussin Maximum Strength Nighttime Cough DM dextromethorphan hydrobromide, doxylamine succinate 30 mg/20mL; 12.5 mg/20mL Solution — NDC 0031-8718-24 (Billing 00031-8718-24)
This is a package of Robitussin Maximum Strength Nighttime Cough DM dextromethorphan hydrobromide, doxylamine succinate 30 mg/20mL; 12.5 mg/20mL Solution from Haleon US Holdings LLC, marketed since Jun 2016 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0031-8718-24 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0031 labeler · 8718 product · 24 package
- Package marketed since
- Jun 1, 2016
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0031871824 7
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 067481
- GCN: 30048
- GPI-14 (Medi-Span): 43995702200930
- HICL (First Databank): 000392
- AHFS class code: 04:04.04.00
- RxCUI (RxNorm): 1115329
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Robitussin Maximum Strength Nighttime Cough is an over-the-counter oral liquid solution marketed under FDA's OTC drug monograph rules. It contains dextromethorphan hydrobromide, a cough suppressant typically used to reduce cough reflex, and doxylamine succinate, a first-generation antihistamine commonly used to promote drowsiness. This combination is typically used in cough and cold products intended for nighttime use, when reducing cough while helping the user sleep may be desired.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00031-8718-13 0031-8718-13 Main listing | 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2016-06-01 | — | Active |
| 00031-8718-18 0031-8718-18 | 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE | 2016-06-01 | — | Active |
| 00031-8718-24 You're viewing this | 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE | 2016-06-01 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Robitussin Maximum Strength Nighttime Cough DM dextromethorphan hydrobromide, doxylamine succinate 30 mg/20mL; 12.5 mg/20mL Solution?
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Haleon US Holdings LLC labeler code 00031
- Childrens Robitussin Nighttime Cough Long-Acting DM chlorpheniramine maleate, dextromethorphan hydrobromide 2 mg/10mL; 15 mg/10mL Solution NDC 0031-8692-13
- CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING chlorpheniramine maleate, dextrometrorphan HBr 2 mg/10mL; 15 mg/10mL Liquid NDC 0031-8693-12
- Childrens Robitussin Cough Long-Acting dextromethorphan hydrobromide 7.5 mg/5mL Liquid NDC 0031-8694-12
- Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide and guaifenesin 20 mg/20mL; 200 mg/20mL Liquid NDC 0031-8702-13
- Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide, guaifenesin 5 mg/5mL; 100 mg/5mL Liquid NDC 0031-8715-10
- Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL Liquid NDC 0031-8716-12
- Robitussin Maximum Strength Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin 10 mg; 200 mg Capsule, Liquid Filled NDC 0031-8719-10
- Childrens Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release NDC 0031-8725-10
- Childrens Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release NDC 0031-8726-10
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Syrup NDC 0031-8729-01
- ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM dextromethorphan hbr, guaifenesin 20 mg/20mL; 400 mg/20mL Solution NDC 0031-8739-12
- Robitussin Peak Cold Multi-Symptom Cold dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid NDC 0031-8742-14
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat controls the impulse to cough to help you sleep
⏱️ Dosage and Administration ▾
Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years do not use
⚠️ Warnings ▾
Warnings Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information each 20 mL contains: sodium 14 mg store at 20-25°C (68-77°F)
🧪 Active Ingredient ▾
Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 30 mg Doxylamine Succinate, USP 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum
🎯 Purpose ▾
Purposes Cough suppressant Antihistamine
📄 Do Not Use ▾
Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
📄 When Using This Product ▾
When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL ADULT Robitussin MAXIMUM STRENGTH Nighttime Cough DM DEXTROMETHORPHAN HBr (Cough Suppressant) DOXYLAMINE SUCCINATE (Antihistamine) Controls Cough Relieves Runny Nose & Sneezing FAST, EFFECTIVE cough relief DM NIGHTTIME MAX For Ages 12 & Over 4 FL OZ (118 mL) Robitussin MS NT Cough 4 oz
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |