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Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL Liquid — NDC 00031-8716-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL Liquid — NDC 0031-8716-12 (Billing 00031-8716-12)

by Haleon US Holdings LLC · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL Liquid from Haleon US Holdings LLC, marketed since Sep 2009 and currently FDA-listed. It is this product's only package size.

NDC 00031-8716-12
🏷️ FDA NDC (as labeled) 0031-8716-12 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 0031-8716-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0031 labeler · 8716 product · 12 package
Package marketed since
Sep 1, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0031871612 0
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0031-8716-12
Product NDC 0031-8716
11-digit billing NDC 00031871612
NCPDP billing unit ML — per mL (volume)
RxCUI 1370205
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M001
SPL Set ID fcd0a8e0-ac2a-039a-be3c-534195d6bcfd
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43997303100905
GPI class Robitussin Child Cough/Cold CF
GCN Seq No 048922
GCN 14903
HICL code 000216
Ingredient (HICL) Guaifen/Dextromethorphan/Pe
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 B4R
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Decongestant-Expectorant
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name ROBITUSSIN COUGH-COLD CF LIQ
FDB brand name Robitussin Cough & Cold Cf
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 048922
  • GCN: 14903
  • GPI-14 (Medi-Span): 43997303100905
  • HICL (First Databank): 000216
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1370205
Why two NDCs? The FDA registers this code as 0031-8716-12 — 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 → 00031-8716-12. 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 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 COUGH-COLD CF LIQ Ingredient Guaifen/Dextromethorphan/Pe
🧪 What is this product?

Childrens Robitussin Cough and Cold CF is an over-the-counter liquid medicine taken by mouth. It combines dextromethorphan, a cough suppressant typically used to reduce cough reflex, with guaifenesin, an expectorant commonly used to help thin mucus and make coughs more productive. The product also contains phenylephrine, a nasal decongestant typically used to temporarily relieve stuffy nose and sinus congestion. This is an OTC monograph product, meaning it follows established FDA guidelines for combination cold and cough medicines.

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
00031-8716-12 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2009-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Robitussin Cough and Cold CF 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mLthis 00031-8716-12 Haleon 1 bottle — — FDA listed —
Tukol Children Cough and Congestion 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL 50066-0308-04 Genomma 1 bottle — — FDA listed —
Tukol A 5 mg/5mL; 50 mg/5mL; 2.5 mg/5mL 50066-0536-24 Genomma 118 ml — — FDA listed —
Mucosan Childrens Multi-Symptom Grape 50 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 53145-0691-04 Menper 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

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 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.

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 applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00031
First marketedSep 2009
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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 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 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation

⏱️ Dosage and Administration 69 words ▾

Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 6 doses in any 24-hour period age dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and over 20 mL every 4 hours

⚠️ Warnings 214 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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 or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever 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 16 words ▾

Other information each 10 mL contains: sodium 7 mg store at 20-25°C (68-77°F). Do not refrigerate.

🧪 Active Ingredient 20 words ▾

Active ingredients (in each 10 mL) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

🎯 Purpose 6 words ▾

Purposes Cough suppressant Expectorant Nasal decongestant

📄 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 48 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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 or Pharmacist Before Use If 18 words ▾

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

📄 When Using This Product 10 words ▾

When using this product do not use more than directed.

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever 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 48 words ▾

PRINCIPAL DISPLAY PANEL Children's Robitussin FOR AGES 4 & OVER Cough & Cold CF DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) PHENYLEPHRINE HCl (Nasal Decongestant) Relieves: Cough Chest Congestion/Mucus Stuffy Nose Non-Drowsy grape flavor 4 FL OZ (118 mL) PAA172104 Front Carton Children Robitussin CC CF 4 oz(118 mL)

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

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.
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.
← 00031-8715-10 · Haleon 00031-8718-13 · 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.