Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 473 mL — NDC 0121-0775-16 (Billing 00121-0775-16)
This is a package of 473 mL of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution from PAI Holdings, LLC, marketed since Oct 2006 and currently FDA-listed; retail pharmacies pay about $0.0327 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0121-0775-16 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0121 labeler · 0775 product · 16 package
- Package marketed since
- Oct 1, 2006
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 473 mL per package
- Barcode (UPC-A, from the NDC)
- 3 0121077516 1
- Medicaid fills, this package
- 28,598 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 1, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 045669
- GCN: 91713
- GPI-14 (Medi-Span): 43997002282020
- HICL (First Databank): 000206
- AHFS class code: 28:08.08.00
- RxCUI (RxNorm): 995868
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Opioid Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.033 | $15.47 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0746 | $35.29 / 473 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00121-0775-04 0121-0775-04 | 118 mL in 1 BOTTLE | $0.0645 / mL | $7.61 | 2006-10-01 | — | Active |
| 00121-0775-08 0121-0775-08 | 237 mL in 1 BOTTLE | $0.0441 / mL | $10.44 | 2006-10-01 | — | Discontinued by firm |
| 00121-0775-16 You're viewing this Main listing | 473 mL in 1 BOTTLE | $0.0327 / mL | $15.47 | 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 ($0.0327 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00121-0775-04?
What NDC number is used to bill for this package of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 | $0.059 | — | Availability likely | +80% |
| Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04 | Westminster | 118 ml | $0.064 | — | Availability likely | +97% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from PAI Holdings, LLC labeler code 00121
- Ranitidine 15 mg/mL Syrup NDC 0121-0727-16
- GUAIFENESIN 100 mg/5mL Solution NDC 0121-0744-04
- Prednisolone Sodium Phosphate 15 mg/5mL Solution NDC 0121-0759-08
- Calcium Carbonate 1250 mg/5mL Suspension NDC 0121-0766-16
- Lorazepam 2 mg/mL Liquid NDC 0121-0770-01
- Prednisolone Sodium Phosphate 10 mg/5mL Solution NDC 0121-0773-08
- Prednisolone Sodium Phosphate 20 mg/5mL Solution NDC 0121-0777-08
- Levetiracetam 100 mg/mL Solution NDC 0121-0799-16
- Nystatin 100000 [USP'U]/mL Suspension NDC 0121-0810-02
- THEOPHYLLINE 80 mg/15mL Solution NDC 0121-0820-04
- OXYCODONE HYDROCHLORIDE 5 mg/5mL Solution NDC 0121-0827-04
- Childrens Ibuprofen Oral Suspension 100 mg/5mL Suspension NDC 0121-0833-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 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
📄 Do Not Use ▾
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 ▾
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 ▾
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 ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
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 ▾
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 ▾
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0775-16 Guaifenesin and Codeine Phosphate Oral Solution USP CV 100 mg/10 mg per 5 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Each teaspoonful (5 mL) contains: Guaifenesin, USP 100 mg Codeine Phosphate, USP 10 mg Dispense in a tight, light-resistant container with a child-resistant closure. DO NOT ACCEPT IF SEAL AROUND CAP IS BROKEN OR MISSING 16 fl oz (473 mL) pai Pharmaceutical Associates, Inc. Greenville, SC 29605 Principal Display Panel - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-1775-05 G UAIFENESIN AND C ODEINE P HOSPHATE O RAL S OLUTION USP CV 100 mg/10 mg per 5 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1550-10 G UAIFENESIN AND C ODEINE P HOSPHATE O RAL S OLUTION USP CV 200 mg/20 mg per 10 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT Principal Display Panel - 10 mL Unit Dose Cup Label - 1775