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Robitussin Honey Severe Cough, Flu Plus Sore Throat acetaminophen, dextromethorphan hbr 650 mg/20mL; 20 mg/20mL Solution — NDC 00031-8771-12 package photo

Robitussin Honey Severe Cough, Flu Plus Sore Throat acetaminophen, dextromethorphan hbr 650 mg/20mL; 20 mg/20mL Solution

by Haleon US Holdings LLC · 1 BOTTLE in 1 CARTON (0031-8771-12) / 118 mL in 1 BOTTLE
NDC 00031-8771-12
🏷️ FDA NDC (as labeled) 0031-8771-12 billing pads the labeler segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 237 mL 00031-8771-18
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0031-8771-12
Product NDC 0031-8771
11-digit billing NDC 00031877112
NCPDP billing unit ML — per mL (volume)
RxCUI 1919076
UNII 362O9ITL9D, 9D2RTI9KYH
Application # M012
SPL Set ID 77be57fb-0ae5-4fad-97f3-b6a4b57383a9
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 OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-15
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
GPI-14 43995502200925
GPI class Robitussin Honey Cgh/Flu/Thrt
GCN Seq No 080839
GCN 47821
HICL code 006331
Ingredient (HICL) Acetaminophen/Dextromethorphan
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 B4A
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Analgesic Combinations
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name ROBITUSSIN HONEY CGH-FLU-SORE
FDB brand name Robitussin Honey Cgh-Flu-Sore
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0031-8771-12 — 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 → 00031-8771-12. 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 Anilides class.

Drug family (ATC) Anilides
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.

🏭 Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00031
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio404 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.

🩺 Clinical

Label name ROBITUSSIN HONEY CGH-FLU-SORE Ingredient Acetaminophen/Dextromethorphan
📖 About the active ingredient: Acetaminophen; Dextromethorphan Hydrobromide MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Robitussin Honey Severe Cough, Flu Plus Sore Throat is an oral liquid solution sold as an over-the-counter monograph product. It contains acetaminophen, typically used to help reduce fever and relieve mild to moderate pain, and dextromethorphan hydrobromide, which is commonly used to help suppress cough. This combination product is intended for use in managing multiple cold and flu symptoms at once.

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.

💊 What it looks like

Color orange
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII U6WSN5SQ1Z
    Zinc gluconate is a form of zinc, a mineral, combined with gluconic acid. It's used as a supplement ingredient to provide zinc content in the formulation.

13 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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: 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Robitussin Maximum Strength Severe Cough Plus Sore Throat 650 mg/20mL; 20 mg/20mL 00031-8750-12 Haleon 1 bottle — — FDA listed —
Robitussin Honey Severe Cough, Flu Plus Sore Throat 650 mg/20mL; 20 mg/20mLthis 00031-8771-12 Haleon 1 bottle — — FDA listed —
CVS Severe Cough, Flu Plus Sore Throat Honey 650 mg/20mL; 20 mg/20mL 51316-0631-08 CVS 1 bottle — — FDA listed —
Cough and Sore Throat 650 mg/20mL; 20 mg/20mL 51316-0662-03 CVS 180 ml — — FDA listed —
Delsym Cough Plus Sore Throat 650 mg/20mL; 20 mg/20mL 63824-0221-66 Reckitt 180 ml — — FDA listed —
DRx Choice maximum strength Severe Cough plus sore throat 650 mg/20mL; 20 mg/20mL 68163-0749-08 RARITAN 1 bottle — — FDA listed —
CVS Severe Tussin CF Max 650 mg/20mL; 20 mg/20mL 69842-0947-08 CVS 1 bottle — — FDA listed —
Mucinex Childrens Fever Sore Throat and Cough 325 mg/10mL; 10 mg/10mL 72854-0064-04 Reckitt 1 bottle — — FDA listed —
Mucinex Childrens Multi-Symptom Cold and Flu 10 mg/10mL; 325 mg/10mL 72854-0070-04 Reckitt 1 bottle — — FDA listed —
Onessip Day Time Kids Cold And Cough Plus Fever 10 mg/10mL; 325 mg/10mL 87078-0331-16 MEDWISE 16 pouches — — 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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.

🔬 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 Honey Severe Cough, Flu Plus Sore Throat (this brand).

Top reported reactions

Recalled Product Administered15
Pneumonia5
Condition Aggravated3
Illness3
Abortion Spontaneous2
Asthenia2
Fatigue2

Reporter sex

22 reports
Male · 31%
Female · 69%

Serious outcomes

Hospitalization7
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00031-8771-12 You're viewing this 1 BOTTLE in 1 CARTON (0031-8771-12) / 118 mL in 1 BOTTLE 2020-06-15 Active
00031-8771-18 1 BOTTLE in 1 CARTON (0031-8771-18) / 237 mL in 1 BOTTLE 2020-06-15 Active

Pack size FAQ

What quantity is in NDC 00031-8771-12?
NDC 00031-8771-12 is listed by the FDA — 1 bottle in 1 carton / 118 ml in 1 bottle.
What NDC number is used to bill for this package of Robitussin Honey Severe Cough, Flu Plus Sore Throat acetaminophen, dextromethorphan hbr 650 mg/20mL; 20 mg/20mL Solution?
Bill NDC 00031-8771-12 — the 11-digit billing format is 00031877112. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) ✓ 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 FDA registers it as 0031-8771-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00031-8771-12, written without dashes as 00031877112. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00031-8771-12, the first segment (00031) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (8771) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
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 1 other package presentation of this same product, including 1 bottle (00031-8771-18). 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.

📄 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
🎯 Indications and Usage 30 words ▾

Uses temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat pain headache temporarily reduces fever

⏱️ Dosage and Administration 79 words ▾

Directions do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. 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

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 doses in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other pain reliever/fever reducer When using this product do not use more than directed. Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

📦 Storage and Handling 17 words ▾

Other information each 20 mL contains : sodium 21 mg store at 20-25°C (68-77°F). Do not refrigerate.

🧪 Active Ingredient 14 words ▾

Active ingredients (in each 20 mL) Acetaminophen, USP 650 mg Dextromethorphan HBr 20 mg

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

🎯 Purpose 6 words ▾

Purposes Pain reliever/Fever reducer Cough suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00031-8770-12 · Haleon 00031-8989-01 · 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.