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Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release — NDC 00031-8753-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release — NDC 0031-8753-03 (Billing 00031-8753-03)

by Haleon US Holdings LLC · 1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE

This is a package of Robitussin 12 Hour Cough Relief dextromethorphan polistirex 30 mg/5mL Suspension, Extended Release from Haleon US Holdings LLC, marketed since Jul 2015 and currently FDA-listed. It is this product's only package size.

NDC 00031-8753-03
🏷️ FDA NDC (as labeled) 0031-8753-03 billing pads the labeler segment with a zero
OTC Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0031-8753-03
Product NDC 0031-8753
11-digit billing NDC 00031875303
NCPDP billing unit ML — per mL (volume)
RxCUI 1373045
UNII 9D2RTI9KYH
Application # ANDA091135
SPL Set ID 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-01
Route ORAL
Dosage form SUSPENSION, EXTENDED RELEASE
Substance DEXTROMETHORPHAN HYDROBROMIDE

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

GPI-14 4310203060G110
GPI class Robitussin 12 Hour Cough
GCN Seq No 004630
GCN 17802
HICL code 010295
Ingredient (HICL) Dextromethorphan Polistirex
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6C
Therapeutic class — specific (HIC3) Antitussives, Non-Opioid
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name ROBITUSSIN ER 30 MG/5 ML SUSP
FDB brand name Robitussin Er
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004630
  • GCN: 17802
  • GPI-14 (Medi-Span): 4310203060G110
  • HICL (First Databank): 010295
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 1373045
Why two NDCs? The FDA registers this code as 0031-8753-03 — 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 → 00031-8753-03. 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 ER 30 MG/5 ML SUSP Ingredient Dextromethorphan Polistirex
📗 Our plain-language guide HelloPharmacist
  • It's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
  • It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
  • Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
  • Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
📖 Read our full Dextromethorphan guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
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
00031-8753-03 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE 2015-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Cough DM 30 mg/5mL 00113-0958-21 L. 1 bottle $0.066 — Availability likely —
cough dm 30 mg/5mL 00904-6312-56 Major 1 bottle $0.066 — Availability likely —
dextromethorphan polistirex extended release 30 mg/5mL 45802-0433-21 Padagis 1 bottle $0.066 — Availability likely —
Good Neighbor Pharmacy Cough DM ER 30 mg/5mL 46122-0141-21 Amerisource 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0187-01 Cardinal 1 bottle $0.066 — Availability likely —
leader childrens cough dm 30 mg/5mL 70000-0195-01 Cardinal 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0302-01 Cardinal 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1025-01 Strategic 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1026-01 Strategic 1 bottle $0.066 — Availability likely —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0173-63 Reckitt 1 bottle $0.102 — FDA listed —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0177-63 Reckitt 1 bottle $0.102 — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8655-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8725-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8726-10 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mLthis 00031-8753-03 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8754-15 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8755-15 Haleon 1 bottle — — FDA listed —
good sense cough dm 30 mg/5mL 00113-0384-21 L. 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 00363-0384-21 Walgreen 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 00363-0494-21 Walgreen 1 bottle — — Discontinued —
childrens cough dm 30 mg/5mL 00363-0899-21 Walgreen 1 bottle — — FDA listed —
up and up 12 hour cough relief 30 mg/5mL 11673-0114-28 Target 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 11822-0384-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0494-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0958-01 Rite 1 bottle — — Discontinued —
cough dm 30 mg/5mL 17856-6312-01 ATLANTIC 5 ml — — FDA listed —
signature care 12 hour cough relief 30 mg/5mL 21130-0012-21 Safeway 1 bottle — — FDA listed —
Signature Care Cough Relief 30 mg/5mL 21130-0520-21 Safeway 1 bottle — — FDA listed —
Cough Dm 30 mg/5mL 21130-0538-21 Safeway 1 bottle — — FDA listed —
signature care childrens 12 hour cough relief 30 mg/5mL 21130-0890-21 Safeway 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 30142-0384-21 Kroger 1 bottle — — FDA listed —
cough dm 30 mg/5mL 30142-0494-21 Kroger 1 bottle — — FDA listed —
TopCare Cough DM 30 mg/5mL 36800-0494-21 Topco 1 bottle — — FDA listed —
Topcare Cough DM 30 mg/5mL 36800-0552-21 Topco 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 37808-0384-21 H 1 bottle — — FDA listed —
equaline cough dm 30 mg/5mL 41163-0384-21 United 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0384-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0494-28 Meijer 1 bottle — — FDA listed —
cough dm childrens 30 mg/5mL 41250-0899-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0958-28 Meijer 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0384-21 American 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0958-21 American 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0384-21 HyVee 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0494-21 HyVee 1 bottle — — FDA listed —
Equate Cough DM 30 mg/5mL 49035-0384-21 Wal-Mart 1 bottle — — FDA listed —
equate cough dm 30 mg/5mL 49035-0899-28 Wal-Mart 1 bottle — — FDA listed —
Delsym 30 mg/5mL 50090-0224-00 A-S 1 bottle — — FDA listed —
12 Hr Relief Cough Dm 30 mg/5mL 51316-0263-21 CVS 1 bottle — — FDA listed —
Childrens 12 Hr Cough Relief 30 mg/5mL 51316-0429-28 CVS 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0384-21 Dolgencorp 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0958-21 Dolgencorp, 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 56062-0384-21 Publix 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0610-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0611-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0617-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0618-05 Aurohealth 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0384-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0709-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0958-21 CVS 1 bottle — — FDA listed —
Delsym 30 mg/5mL 63824-0171-22 Reckitt 1 cello — — FDA listed —
Delsym 30 mg/5mL 63824-0175-22 Reckitt 1 cello — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mL 65162-0700-76 Amneal 1 bottle — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mL 65162-0799-76 Amneal 1 bottle — — FDA listed —
dextromethorphan polistirex extended release 30 mg/5mL 72162-2281-02 Bryant 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0384-28 Amazon.com 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0494-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0899-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0958-28 Amazon.com 1 bottle — — FDA listed —
12 hr relief cough dm 30 mg/5mL 51316-0943-21 CVS 1 bottle — — FDA listed —
cough dm 30 mg/5mL 72288-0389-28 Amazon.com 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 orange / purple
FlavorGrape
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
Application holderTRIS PHARMA INC
FDA applicationANDA091135 (ANDA)
Labeler code00031
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio405 products on file
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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

⏱️ Dosage and Administration 104 words ▾

Directions shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products dose as follows or as directed by doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

⚠️ Warnings 172 words ▾

Warnings 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. Allergy Alert Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 1-800-222-1222.

📦 Storage and Handling 16 words ▾

Other information each 5 mL contains: sodium 5 mg store at 20-25°C (68-77°F) dosing cup provided

🧪 Active Ingredient 15 words ▾

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

🧪 Inactive Ingredients 80 words ▾

Inactive ingredients (Grape flavor) D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Inactive ingredients (Orange flavor) D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

🎯 Purpose 3 words ▾

Purpose Cough suppressant

📄 Do Not Use 55 words ▾

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 27 words ▾

Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

📄 Stop Use and Ask a Doctor If 45 words ▾

Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.

📄 Questions or Comments 29 words ▾

Questions? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675 . You may also report side effects to this number. For most recent product information, visit www.robitussin.com

📄 Package Label / Principal Display Panel 215 words ▾

PRINCIPAL DISPLAY PANEL Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Orange Flavored Liquid Alcohol-Free 3 FL OZ (89 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Orange 3 FL OZ(89 mL)

PRINCIPAL DISPLAY PANEL NEW SIZE! Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Orange Flavored Liquid Alcohol-Free 5 FL OZ (148 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Orange 5 FL OZ (148 mL)

PRINCIPAL DISPLAY PANEL Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Grape Flavored Liquid Alcohol-Free 3 FL OZ (89 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Grape 3 FL OZ (89 mL)

PRINCIPAL DISPLAY PANEL NEW SIZE! Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Grape Flavored Liquid Alcohol-Free 5 FL OZ (148 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Grape 5 FL OZ (148 mL)

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 Robitussin 12 Hour Cough Relief (this brand).

Top reported reactions

Diarrhoea70
Dizziness42
Drug Effect Incomplete34
Nausea34
Hypersensitivity27
Somnolence26
Condition Aggravated25

Age at onset

Adult12
Elderly3

Reporter sex

686 reports
Male · 28%
Female · 72%

Serious outcomes

Hospitalization22
Death4
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 140 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

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.
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.
← 00031-8752-12 · Haleon 00031-8754-15 · Haleon →
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.