Robitussin Day and Night Maximum Strength Cough DM dextromethorphan hydrobromide, guaifenesin, doxylamine succinate Kit — NDC 0031-2103-01 (Billing 00031-2103-01)
This is a package of Robitussin Day and Night Maximum Strength Cough DM dextromethorphan hydrobromide, guaifenesin, doxylamine succinate Kit from Haleon US Holdings LLC, marketed since Mar 2021 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0031-2103-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0031 labeler · 2103 product · 01 package
- Package marketed since
- Mar 1, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0031210301 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1020138
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 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
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Read the full MedlinePlus article ↗- It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
- Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
- How do I take the extended-release tablets?
- The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
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 5, 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 each | 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 5, 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 |
|---|---|---|---|---|
| 00031-2103-01 You're viewing this Main listing | 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2021-03-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Robitussin Day and Night Maximum Strength Cough DMthis 00031-2103-01 | Haleon | 1 kit | — | — | FDA listed | — |
| Robitussin Day and Night Cough Relief DM Max 00031-2834-01 | Haleon | 1 kit | — | — | FDA listed | — |
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 5, 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.
This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.
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 5, 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
- Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime acetaminophen, diphenhydramine hcl 650 mg/20mL; 25 mg/20mL Liquid NDC 0031-0101-04
- Robitussin Honey Cough DM Day Night Value Pack dextromethorphan HBr, guaifenesin, doxylamine succinate Kit NDC 0031-2059-01
- Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM dextromethorphan HBr, guaifenesin 20 mg/20mL; 400 mg/20mL Solution NDC 0031-2097-01
- Childrens Robitussin Elderberry Cough and Chest Congestion DM dextromethorphan HBr, guaifenesin 20 mg/20mL; 400 mg/20mL Solution NDC 0031-2098-01
- Robitussin Day and Night Cough Relief Value Pack dextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate Kit NDC 0031-2099-01
- Robitussin Childrens Honey Day Night DM Value Pack dextromethorphan HBr, guaifenesin, doxylamine succinate Kit NDC 0031-2102-01
- Robitussin Day and Night Cough Relief DM Max dextromethorphan hydrobromide, guaifenesin, doxylamine succinate Kit NDC 0031-2834-01
- Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release NDC 0031-8655-10
- 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
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 – Robitussin Maximum Strength Cough+Chest Congestion DM 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
Uses – Robitussin Maximum Strength Nighttime Cough DM 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 – Robitussin Maximum Strength Cough+Chest Congestion DM do not take more than 6 doses in any 24 hour period measure only with dosing cup provided keep dosing cup with product mL = milliliter 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 4 hours children under 12 years do not use
Directions – Robitussin Maximum Strength Nighttime Cough DM 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 – Robitussin Maximum Strength Cough+Chest Congestion DM Do not use 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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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.
Warnings – Robitussin Maximum Strength Nighttime Cough DM 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 a 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.
🧪 Active Ingredient ▾
Active ingredients (in each 20 mL) – Robitussin Maximum Strength Cough+Chest Congestion DM Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg
Active ingredients (in each 20 mL) – Robitussin Maximum Strength Nighttime Cough DM Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients – Robitussin Maximum Strength Cough+Chest Congestion DM 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
Inactive ingredients – Robitussin Maximum Strength Nighttime Cough DM 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 – Robitussin Maximum Strength Cough+Chest Congestion DM Cough suppressant Expectorant
Purposes – Robitussin Maximum Strength Nighttime Cough DM Cough suppressant Antihistamine
📄 Do Not Use ▾
Do not use 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.
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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a 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.
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.
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? – Robitussin Maximum Strength Cough+Chest Congestion DM call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Questions or comments? – Robitussin Maximum Strength Nighttime Cough DM call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
📄 Package Label / Principal Display Panel ▾
Principal Display Panel – Robitussin Maximum Strength Cough+Chest Congestion DM ADULT Robitussin MAXIMUM STRENGTH Cough+Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Controls Cough Relieves Chest Congestion Thins & Loosens Mucus FAST, EFFECTIVE cough relief DM MAX For Ages 12 & Over 4 FL OZ (118 mL) Robitussin MS Cough Plus Chest Congestion DM 4 FL OZ
Principal Display Panel – Robitussin Maximum Strength Nighttime Cough DM 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 Nighttime Cough DM 4 fl oz
Principal Display Panel – Robitussin Maximum Strength Day/Night Value Pack DAY&NIGHT VALUE PACK ADULT Robitussin MAXIMUM STRENGTH COUGH+CHEST CONGESTION DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Controls Cough Relives Chest Congestion Thins & Loosens Mucus FAST, EFFECTIVE cough relief DM MAX For Ages 12 & Over 4 FL OZ (118 mL) 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 Kit Day Night DM Max 4 oz plus 4 oz
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | ✓ 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. |