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Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 237 mL — NDC 00121-0775-08 package photo

Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 237 mL

by PAI Holdings, LLC · 237 mL in 1 BOTTLE (0121-0775-08)
NDC 00121-0775-08
🏷️ FDA NDC (as labeled) 0121-0775-08 billing pads the labeler segment with a zero
This package
Contains237 mL Cost per mL$0.0441 NADAC Per package$10.45 / 237 ml Pack sizes3 compare ↓
Also comes in: 118 ml 00121-0775-04 473 ml 00121-0775-16
OTC Discontinued CV ⚠ Discontinued by firm
🗂️ 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 →

This page is curated, coded, and maintained by

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

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
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0121-0775-08
Product NDC 0121-0775
11-digit billing NDC 00121077508
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2006-10-01
Route ORAL
Dosage form SOLUTION
Substance GUAIFENESIN; CODEINE PHOSPHATE
GPI-14 43997002282020
GPI class guaiFENesin-Codeine
GCN Seq No 045669
GCN 91713
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 GUAIFEN-CODEINE 100-10 MG/5 ML
FDB brand name Guaifenesin-Codeine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0121-0775-08 — 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 → 00121-0775-08. 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 GUAIFEN-CODEINE 100-10 MG/5 ML Ingredient Codeine Phosphate/Guaifenesin
🧪 What is this product?

This is an oral liquid cough and cold product sold over the counter under FDA's OTC monograph rules. Guaifenesin is an expectorant typically used to help thin and clear mucus from the airways. Codeine phosphate is a cough suppressant commonly used to reduce cough reflex. Together, these ingredients are formulated to address both mucus buildup and cough symptoms during respiratory illness.

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 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.044 $10.45 / 237 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 May 2022 Sep 2022 Feb 2023 $0.053 $0.041
▼ Down 17% over the last 10 months.
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
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mLthis 00121-0775-08 PAI 237 ml $0.044 — Discontinued —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 58657-0500-04 Method 120 ml $0.057 — Availability likely +30%
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04 Westminster 118 ml $0.065 — Availability likely +46%
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/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.
473 ml00121-0775-16 34,992 Rx · $443,047
118 ml00121-0775-04 7,618 Rx · $115,882
237 ml this page00121-0775-08 No Medicaid data
Drug total (last 4 qtrs): 42,610 Rx · 6,701,676 units · $558,929 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 NDCDescription Per unit Per pack Marketing startStatus
00121-0775-04 118 mL in 1 BOTTLE (0121-0775-04) $0.0645 / mL $7.62 2006-10-01 Active
00121-0775-08 You're viewing this 237 mL in 1 BOTTLE (0121-0775-08) $0.0441 / mL $10.44 2006-10-01 Discontinued by firm
00121-0775-16 473 mL in 1 BOTTLE (0121-0775-16) $0.0331 / mL $15.66 2006-10-01 Active

You're viewing one of 3 pack sizes for this product.

Per mL, this pack runs about 33% above the cheapest pack (473 mL, $0.0331 vs $0.0441 NADAC).

This pack shows little to no recent Medicaid volume — the 473 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00121-0775-08?
NDC 00121-0775-08 contains 237 mL — 237 ml in 1 bottle.
What is the difference between NDC 00121-0775-08 and NDC 00121-0775-04?
Both are Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution — the drug itself is identical. NDC 00121-0775-08 is the 237 mL package, while NDC 00121-0775-04 is the 118 ml package. Per-mL NADAC also differs: $0.0441 here vs $0.0645 for the 118 ml pack.
What NDC number is used to bill for this package of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution?
Bill NDC 00121-0775-08 — the 11-digit billing format is 00121077508. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0121-0775-08, 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: 00121-0775-08, written without dashes as 00121077508. 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 00121-0775-08, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC; the middle segment (0775) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 118 ml (00121-0775-04), 473 ml (00121-0775-16). 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 34 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 85 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 180 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 33 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)

🧪 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0773-08 · PAI 00121-0777-08 · PAI →
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.