Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution
by PAI Holdings, LLC · 10 TRAY in 1 CASE (0121-1775-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
NDC 00121-1775-10
🏷️ FDA NDC (as labeled)
0121-1775-10
billing pads the labeler segment with a zero
This package
Contains10 mL in 1 cup, unit-dose
Pack sizes3 compare ↓
OTC
On market
CV
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (1)
Class III · Jan 7, 2025 · Terminated — Superpotent; sodium benzoate preservative (PAI Holdings, LLC. dba Pharmaceutical Associates Inc) · FDA recall D-0222-2025
🆔 Identity & classification
FDA NDC (as labeled)
0121-1775-10
Product NDC
0121-1775
11-digit billing NDC
00121177510
NCPDP billing unit
ML — per mL (volume)
RxCUI
995868
UNII
GSL05Y1MN6, 495W7451VQ
Application #
M012
SPL Set ID
88d0994c-4270-4408-8837-bd97510b2118
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
2006-10-01
Route
ORAL
Dosage form
SOLUTION
Substance
GUAIFENESIN; CODEINE PHOSPHATE
GPI-14
43997002282020
GPI class
guaiFENesin-Codeine
GCN Seq No
070993
GCN
34673
HICL code
000206
Ingredient (HICL)
Codeine Phosphate/Guaifenesin
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
B4S
Therapeutic class — specific (HIC3)
Opioid Antitussive-Expectorant Combination
AHFS code
28:08.08.00
AHFS class
Opioid Agonists (28:08)
FDB label name
GUAIFENESIN-CODEINE SYRUP
FDB brand name
Guaifenesin-Codeine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0121-1775-10 — 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 → 00121-1775-10. 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.
🏭 Manufacturer & labeler
LabelerPAI Holdings, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedOct 2006
DEA scheduleCV
Product typeHuman Otc Drug
Portfolio5 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 GUAIFENESIN-CODEINE SYRUP Ingredient Codeine Phosphate/Guaifenesin
🧪 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 typically used to help thin and loosen mucus so it is easier to cough up, and codeine phosphate, an opioid commonly used to suppress cough. The combination is intended to address both chest congestion and persistent cough associated with colds and upper respiratory conditions.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Guaifenesin and Codeine Phosphate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
red
FlavorCherry
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.
💲 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 system | Per mL | Per 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/5mLthis 00121-1775-10 | 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/5mL 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
🏛️
2006
On the market since
Oct 2006
📍
2026
Currently FDA-listed
20 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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 24 Rx · 34 units · $70 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00121-1775-00 | 10 TRAY in 1 CASE (0121-1775-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05) | 2006-10-01 | Active |
| 00121-1775-10 You're viewing this | 10 TRAY in 1 CASE (0121-1775-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE | 2006-10-01 | Active |
| 00121-1775-40 | 4 TRAY in 1 CASE (0121-1775-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05) | 2024-01-10 | Active |
Pack size FAQ
What quantity is in NDC 00121-1775-10?
NDC 00121-1775-10 is listed by the FDA — 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose.
What NDC number is used to bill for this package of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution?
Bill NDC 00121-1775-10 — the 11-digit billing format is 00121177510. 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) | — 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 FDA registers it as 0121-1775-10, 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: 00121-1775-10, written without dashes as 00121177510. 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 00121-1775-10, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC; the middle segment (1775) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 PAI Holdings, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 cups (00121-1775-00), 10 cups (00121-1775-40). 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?
PAI 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 ▾
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 ▾
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 ▾
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 ▾
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)
🧪 Active Ingredient ▾
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
🧪 Inactive Ingredients ▾
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 ▾
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.