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Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 473 mL — NDC 00121-0775-16 package photo

Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 473 mL

by PAI Holdings, LLC · 473 mL in 1 BOTTLE (0121-0775-16)
NDC 00121-0775-16
🏷️ FDA NDC (as labeled) 0121-0775-16 billing pads the labeler segment with a zero
This package
Contains473 mL Cost per mL$0.0331 NADAC Per package$15.66 / 473 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.0776/unit — full pricing hub ↓
Also comes in: 118 ml 00121-0775-04 237 ml 00121-0775-08
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 →

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

🆔 Identity & classification

FDA NDC (as labeled) 0121-0775-16
Product NDC 0121-0775
11-digit billing NDC 00121077516
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 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 0121-0775-16 — 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 → 00121-0775-16. 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.

💡 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesCitric 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.

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 $0.033 $15.66 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0776 $36.70 / 473 ml
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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.037 $0.025
▲ Up 32% over the last 24 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 00121-0775-16 PAI 473 ml $0.033 — Availability likely —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 58657-0500-04 Method 120 ml $0.057 — Availability likely +74%
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04 Westminster 118 ml $0.065 — Availability likely +95%
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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00121-0775-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
35K
Units reimbursed last 4 qtrs
5.7M
Gross reimbursed last 4 qtrs
$443K
Avg / prescription
$12.66
Avg / unit
$0.0776
Latest quarter Q4 2025
7.1KRx
Medicaid pays / mL
$0.0776
gross reimbursed
vs
NADAC / mL
$0.0331
acquisition cost
=
Spread
+$0.0445
+134% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 16,367 Rx Managed care · 18,625 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 45,258 units · 3,998 per 100k residents MT North Dakota: 33,743 units · 4,309 per 100k residents ND Minnesota: 251,760 units · 4,388 per 100k residents MN Wisconsin: 212,331 units · 3,593 per 100k residents WI Michigan: 85,792 units · 855 per 100k residents MI New York: no data reported NY Vermont: 24,247 units · 3,748 per 100k residents VT New Hampshire: 12,295 units · 877 per 100k residents NH Oregon: 84,636 units · 1,999 per 100k residents OR Nevada: 4,617 units · 145 per 100k residents NV Wyoming: 5,471 units · 937 per 100k residents WY South Dakota: 28,047 units · 3,052 per 100k residents SD Iowa: no data reported IA Illinois: 247,191 units · 1,970 per 100k residents IL Indiana: 97,788 units · 1,425 per 100k residents IN Ohio: 218,499 units · 1,854 per 100k residents OH Pennsylvania: 225,947 units · 1,743 per 100k residents PA New Jersey: 91,911 units · 989 per 100k residents NJ Massachusetts: 8,699 units · 124 per 100k residents MA California: 1,911,612 units · 4,906 per 100k residents CA Utah: 40,254 units · 1,178 per 100k residents UT Colorado: 9,952 units · 169 per 100k residents CO Nebraska: 2,207 units · 112 per 100k residents NE Missouri: 127,433 units · 2,057 per 100k residents MO Kentucky: 99,622 units · 2,201 per 100k residents KY West Virginia: no data reported WV Virginia: 494,912 units · 5,678 per 100k residents VA Maryland: 287,432 units · 4,651 per 100k residents MD Connecticut: 309,512 units · 8,557 per 100k residents CT Rhode Island: 128,697 units · 11,753 per 100k residents RI Arizona: 33,284 units · 448 per 100k residents AZ New Mexico: 29,294 units · 1,386 per 100k residents NM Kansas: no data reported KS Arkansas: 2,870 units · 93.6 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 100,998 units · 1,880 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 51,468 units · 1,751 per 100k residents MS Alabama: no data reported AL Georgia: 49,070 units · 445 per 100k residents GA D.C.: 13,943 units · 2,053 per 100k residents DC Hawaii: 9,074 units · 632 per 100k residents HI Texas: 255,057 units · 836 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
93.611,753
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 11,753 /100k
2 Connecticut 8,557 /100k
3 Virginia 5,678 /100k
4 California 4,906 /100k
5 Maryland 4,651 /100k
6 Minnesota 4,388 /100k
7 North Dakota 4,309 /100k
8 Montana 3,998 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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 ml this page00121-0775-16 34,992 Rx · $443,047
118 ml00121-0775-04 7,618 Rx · $115,882
237 ml00121-0775-08 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
00121-0775-08 237 mL in 1 BOTTLE (0121-0775-08) $0.0441 / mL $10.44 2006-10-01 Discontinued by firm
00121-0775-16 You're viewing this 473 mL in 1 BOTTLE (0121-0775-16) $0.0331 / mL $15.66 2006-10-01 Active

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

This pack has the lowest per-mL cost of the 3 priced pack sizes ($0.0331 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 82% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00121-0775-16?
NDC 00121-0775-16 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 00121-0775-16 and NDC 00121-0775-04?
Both are Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution — the drug itself is identical. NDC 00121-0775-16 is the 473 mL package, while NDC 00121-0775-04 is the 118 ml package. Per-mL NADAC also differs: $0.0331 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 00121-0775-16 — the 11-digit billing format is 00121077516. 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.

📄 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.