Robitussin Maximum Strength Nighttime Cough DM dextromethorphan hydrobromide, doxylamine succinate 30 mg/20mL; 12.5 mg/20mL Solution — NDC 00031-8718-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

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)

by Haleon US Holdings LLC · 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE

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 00031-8718-24
🏷️ FDA NDC (as labeled) 0031-8718-24 billing pads the labeler segment with a zero
This package
Contains355 mL in 1 bottle Pack sizes3 compare ↓
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

FDA NDC (as labeled) 0031-8718-24
Product NDC 0031-8718
11-digit billing NDC 00031871824
RxCUI 1115329
UNII 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID 44feee2f-25bc-48d4-8e13-db1d9daaaa90
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-01
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43995702200930
GPI class Robitussin Nighttime Cough DM
GCN Seq No 067481
GCN 30048
HICL code 000392
Ingredient (HICL) Dextromethorphan Hb/Doxylamine
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4E
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-1St Gen Antihistamine Comb.
AHFS code 04:04.04.00
AHFS class Ethanolamine Derivatives
FDB label name ROBITUSSIN NIGHT COUGH DM LIQ
FDB brand name Robitussin Nighttime Cough Dm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 0031-8718-24 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00031-8718-24. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ROBITUSSIN NIGHT COUGH DM LIQ Ingredient Dextromethorphan Hb/Doxylamine
🧪 What is this product?

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.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 118 mL 237 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
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?
This package is listed by the FDA — 1 bottle in 1 carton / 355 ml in 1 bottle.
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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Robitussin Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mLthis 00031-8718-24 Haleon 1 bottle — — FDA listed —
Robitussin Honey Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 00031-8758-12 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Honey Nighttime Cough DM 15 mg/10mL; 6.25 mg/10mL 00031-8762-12 Haleon 1 bottle — — FDA listed —
Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength 30 mg/20mL; 12.5 mg/20mL 00363-0758-04 WALGREEN 1 bottle — — FDA listed —
Tussin DM Max NIGHTTIME 30 mg/20mL; 12.5 mg/20mL 00363-1043-19 Walgreen 1 bottle — — FDA listed —
tussin nighttime cough 30 mg/20mL; 12.5 mg/20mL 11822-6005-00 Rite 1 bottle — — FDA listed —
topcare tussin dm max 30 mg/20mL; 12.5 mg/20mL 36800-0788-26 Topco 1 bottle — — FDA listed —
meijer Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 41250-0758-04 MEIJER 1 bottle — — FDA listed —
careone tussin dm 30 mg/20mL; 12.5 mg/20mL 41520-0826-26 American 1 bottle — — FDA listed —
tussin dm nighttime max 30 mg/20mL; 12.5 mg/20mL 42507-0689-26 HyVee 1 bottle — — FDA listed —
Tussin DM Max Nighttime 30 mg/20mL; 12.5 mg/20mL 49035-0943-19 Wal-Mart 1 bottle — — FDA listed —
Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 50844-0043-36 L.N.K. 1 bottle — — FDA listed —
Nighttime Cough 30 mg/20mL; 12.5 mg/20mL 51316-0062-26 CVS 1 bottle — — FDA listed —
Tussin DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0430-36 CVS 1 bottle — — FDA listed —
Cough DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0431-36 CVS 1 bottle — — FDA listed —
Safetussin PM Nighttime Cough relief 7.5 mg/5mL; 3.125 mg/5mL 55505-0221-33 Kramer 1 bottle — — Discontinued —
dg health tussin 30 mg/20mL; 12.5 mg/20mL 55910-0709-26 Dolgencorp, 1 bottle — — FDA listed —
Childrens HoneyWorks Plus Nighttime Cough Syrup 15 mg/10mL; 6.25 mg/10mL 68163-0661-04 RARITAN 1 bottle — — FDA listed —
Tussin DM 30 mg/20mL; 12.5 mg/20mL 69842-0699-26 CVS 1 bottle — — FDA listed —
AMAZON Maximim Strength Adult Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 72288-0587-04 AMAZON.COM 1 bottle — — FDA listed —
Nighttime Cough Dm 30 mg/20mL; 12.5 mg/20mL 51316-0791-26 CVS 1 bottle — — FDA listed —
nighttime cough dm 30 mg/20mL; 12.5 mg/20mL 79481-6101-01 Meijer, 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red
FlavorBerry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00031
First marketedJun 2016
Product typeHuman Otc Drug
Portfolio405 products on file

More NDCs from Haleon US Holdings LLC labeler code 00031

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 51 words ▾

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 62 words ▾

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 ~1 min read ▾

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 13 words ▾

Other information each 20 mL contains: sodium 14 mg store at 20-25°C (68-77°F)

🧪 Active Ingredient 16 words ▾

Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 30 mg Doxylamine Succinate, USP 12.5 mg

🧪 Inactive Ingredients 37 words ▾

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 4 words ▾

Purposes Cough suppressant Antihistamine

📄 Do Not Use 65 words ▾

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 44 words ▾

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 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

📄 When Using This Product 40 words ▾

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 32 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 14 words ▾

Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

📄 Package Label / Principal Display Panel 47 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dextromethorphan hydrobromide, doxylamine succinate — the ingredient across all brands.

Top reported reactions

Covid-19178
Nasopharyngitis138
Disease Recurrence135
Cough122
Fatigue118
Nausea112
Diarrhoea93

Reporter sex

0 reports

Serious outcomes

Hospitalization326
Death63
Life-threatening61
Disabling29
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 141 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (00031-8718-13), 1 bottle (00031-8718-18). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Haleon US Holdings LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.