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Guaifenesin and Codeine Phosphate 10 mg/5mL; 100 mg/5mL Solution — NDC 55154-5791-5 (Billing 55154-5791-05)

by Cardinal Health 107, LLC · 5 CUP, UNIT-DOSE in 1 BAG / 10 mL in 1 CUP, UNIT-DOSE

This is a package of Guaifenesin and Codeine Phosphate 10 mg/5mL; 100 mg/5mL Solution from Cardinal Health 107, LLC, marketed since Jun 2023 and currently FDA-listed. It is this product's only package size.

NDC 55154-5791-05
🏷️ FDA NDC (as labeled) 55154-5791-5 billing pads the package segment with a zero
OTC On market CV ⇄ 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) 55154-5791-5
Product NDC 55154-5791
11-digit billing NDC 55154579105
RxCUI 995868
UNII GSL05Y1MN6, 495W7451VQ
UPC 0055154579155
Application # M012
SPL Set ID a9130f36-4761-4e6b-a383-eca3db06ea93
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule CV
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-27
Route ORAL
Dosage form SOLUTION
Substance CODEINE PHOSPHATE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 995868
Why two NDCs? The FDA registers this code as 55154-5791-5 — a 5-4-1 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 package segment → 55154-5791-05. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opium alkaloids and derivatives
How it works Full Opioid 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

🧪 What is this product?

This is an oral liquid cough and cold product sold over the counter as an OTC monograph drug. It contains guaifenesin, an expectorant commonly used to help thin mucus and make cough more productive, and codeine phosphate, a cough suppressant typically used to reduce cough reflex. The combination is intended for temporary relief of cough due to minor throat and bronchial irritation.

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
55154-5791-05 You're viewing this Main listing 5 CUP, UNIT-DOSE in 1 BAG / 10 mL in 1 CUP, UNIT-DOSE 2023-06-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 58657-0500-04 Method 120 ml $0.059 — Availability likely —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 00121-0775-04 PAI 118 ml $0.064 — Availability likely —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04 Westminster 118 ml $0.064 — Availability likely —
Guaifenesin and Codeine Phosphate 200 mg/10mL; 20 mg/10mL 00121-1550-00 PAI 10 cups — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 00121-1775-00 PAI 10 cups — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 50090-1428-00 A-S 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 50090-6435-00 A-S 118 ml — — FDA listed —
Guaifenesin and Codeine Phosphate 10 mg/5mL; 100 mg/5mLthis 55154-5791-05 Cardinal 5 cups — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 68071-5173-04 NuCare 120 ml — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 68788-8361-01 Preferred 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 71205-0624-04 Proficient 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 72162-1669-02 Bryant 120 ml — — 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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

LabelerCardinal Health 107, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55154
First marketedJun 2023
DEA scheduleCV
Product typeHuman Otc Drug
Portfolio477 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 📄 Ask a Doctor or Pharmacist 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 36 words ▾

Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

⏱️ Dosage and Administration 89 words ▾

Directions • take every 4 hours • do not exceed 6 doses in 24 hours • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age • giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor

⚠️ Warnings 186 words ▾

Warnings Do not use • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have • a cough with too much phlegm (mucus) • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparation is not recommended for children under 2 years of age.

📦 Storage and Handling 77 words ▾

Other information • Sodium Content: 5 mg/5 mL • Tamper evident: Do not use if seal under cap is broken or missing • Keep container closed and store away from heat • Store at 20°- 25°C (68°-77°F) Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

🧪 Active Ingredient 20 words ▾

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

🎯 Purpose 20 words ▾

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

📄 Do Not Use 30 words ▾

Do not use • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

📄 Ask a Doctor Before Use If 31 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 38 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 36 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparation is not recommended for children under 2 years of age.

📄 Questions or Comments 23 words ▾

Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.

📄 Package Label / Principal Display Panel 26 words ▾

Principal Display Panel CV NDC 55154-5791-5 GUAIFENESIN AND CODEINE PHOSPHATE ORAL SOLUTION USP 100 mg/10 mg per 5 mL 5 CUPS 100mg/10mg per 5mL bag label

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 Guaifenesin and Codeine Phosphate — the ingredient across all brands.

Top reported reactions

Nausea22
Diarrhoea19
Fatigue19
Pain14
Rash13
Vomiting13
Hypertension12

Age at onset

Adult20
Elderly16

Reporter sex

126 reports
Male · 29%
Female · 70%
Unknown · 1%

Serious outcomes

Hospitalization43
Death17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 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 — Not published for this NDC No photo available yet for this listing.
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 Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, 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.
← 55154-5790-05 · Cardinal 55154-5882-00 · Cardinal →
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.