Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin and Codeine Phosphate NDC 0121-1550
Guaifenesin 200 mg/10mL; Codeine phosphate 20 mg/10mL · Solution · Oral · PAI Holdings, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0121-1550Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1550Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1550-00 | 00121155000 | 10 TRAY in 1 CASE (0121-1550-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10)Marketed from Oct 1, 2006 | |
| 0121-1550-40 | 00121155040 | 4 TRAY in 1 CASE (0121-1550-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10)Marketed from Jan 10, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Guaifenesin and Codeine Phosphate
- Generic name (nonproprietary)
- guaifenesin and codeine phosphate
- Active ingredients
- Guaifenesin — 200 mg/10mLCodeine phosphate — 20 mg/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- PAI Holdings, LLCNDC labeler code 0121
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Full Opioid Agonists (Mechanism)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 0121-1550_2175415b-f07e-50a6-e063-6394a90acabeSPL ID 2175415b-f07e-50a6-e063-6394a90acabeSPL set ID 88d0994c-4270-4408-8837-bd97510b2118RxCUI 995868UNII GSL05Y1MN6, 495W7451VQ
- Pharmacologic class
- Expectorant; Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400121155000followed by a unit qualifier and the quantityPackage 00121-1550-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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
Excerpt only. Read the full label for complete information.
About NDC 0121-1550
- What is NDC 0121-1550?
- 0121-1550 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 200 mg/10mL; Codeine phosphate 20 mg/10mL solution, listed with the FDA by PAI Holdings, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Codeine Phosphate.
- What is the active ingredient?
- Guaifenesin, Codeine phosphate.
- Who is the labeler?
- PAI Holdings, LLC, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guaifenesin and Codeine Phosphate?
- 5 other product NDCs are listed under this name. See all Guaifenesin and Codeine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin and Codeine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guaifenesin and Codeine Phosphate | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Cardinal Health 107, LLC | 55154-5791 | 55154-5791-05 |
| Guaifenesin and Codeine Phosphate | Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8361 | 68788-8361-01 |
| Guaifenesin and Codeine Phosphate | Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | PAI Holdings, LLC | 0121-0775 | 00121-0775-0400121-0775-16 |
| Guaifenesin and Codeine Phosphate | Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | PAI Holdings, LLC | 0121-1775 | 00121-1775-0000121-1775-1000121-1775-40 |
| Guaifenesin and Codeine Phosphate | Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-1428 | 50090-1428-00 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cold and Flu HBPacetaminophen, chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-120 |
| Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | WALMART INC. | 79903-417 |
| Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0343 |
| Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-572 |
| SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-450 |
| Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients | LiquidOral | TARGET CORPORATION | 11673-828 |
| Freegells Cough Drops Menthol Cherry 30ctmenthol | Levomenthol 5.8 mg/1 | LozengeOral | RL Albert & Son Inc. | 83002-040 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-173 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Dextrum Laboratories, Inc | 65852-020 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-878 |
| Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HARRIS TEETER | 72036-274 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl | Acetaminophen 1000 mg/30mL + 3 more ingredients | SyrupOral | Haleon US Holdings LLC | 0067-0114 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin | — | Kit | WALMART INC. | 79903-414 |
| Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | MEIJER DISTRIBUTION INC | 79481-6308 |
| Menthol Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Target Corporation Inc. | 82442-001 |
| adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Meijer Distribution Inc | 41250-261 |
| Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Advanced Generic Corporation | 45737-250 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 |
| Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl | — | Kit | L.N.K. International, Inc. | 50844-529 |
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