Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin and Codeine Phosphate NDC 0121-0775
Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL · Solution · Oral · PAI Holdings, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0121-0775Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0775Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0775-04 | 00121077504 | 118 mL in 1 BOTTLE (0121-0775-04)Marketed from Oct 1, 2006 | |
| 0121-0775-16 | 00121077516 | 473 mL in 1 BOTTLE (0121-0775-16)Marketed from Oct 1, 2006 |
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 — 100 mg/5mLCodeine phosphate — 10 mg/5mL
- 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 0121-0775_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
N400121077504followed by a unit qualifier and the quantityPackage 00121-0775-04. 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 0121-0775
- What is NDC 0121-0775?
- 0121-0775 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL 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 200 mg/10mL; Codeine phosphate 20 mg/10mL | SolutionOral | PAI Holdings, LLC | 0121-1550 | 00121-1550-0000121-1550-40 |
| 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 |
|---|---|---|---|---|
| 12 Hour Nasal Decongestant Extra Moisturizingnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-377 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | Sheffield Pharmaceuticals LLC | 11527-140 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solution | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | SolutionOral | Lil' Drug Store products, Inc. | 66715-6416 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| 4 Way Fast Actingphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | Haleon US Holdings LLC | 0067-2086 |
| 7 Select Maximum Strengthdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | 7-ELEVEN | 10202-740 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-101 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hcl | Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0188 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-228 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | — | KitOral | CVS Pharmacy, Inc | 51316-984 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-122 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-322 |
| Acetaminophen, Dextromethorphan HBr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-036 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | Guaifenesin 200 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0184 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0185 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | — | KitOral | CVS Pharmacy, Inc | 51316-609 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-628 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0154 |
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