Over-the-counter drug · OTC MONOGRAPH DRUG
Codeine-Guaifenesin (Codeine phosphate and guaifenesin) NDC 69367-272
Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL · Solution · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69367-272Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0272Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-272-04 | 6936702720469367027204 | 118 mL in 1 BOTTLE (69367-272-04)Marketed from Jul 15, 2020 | |
| 69367-272-16 | 6936702721669367027216 | 473 mL in 1 BOTTLE (69367-272-16)Marketed from Jul 15, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Codeine-Guaifenesin
- Generic name (nonproprietary)
- codeine phosphate and guaifenesin
- Active ingredients
- Codeine phosphate — 10 mg/5mLGuaifenesin — 100 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- 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 69367-272_447eca2f-cbca-4ae6-bcd9-dfac47105319SPL ID 447eca2f-cbca-4ae6-bcd9-dfac47105319
- 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
N469367027204followed by a unit qualifier and the quantityPackage 69367-0272-04. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69367-272
- What is NDC 69367-272?
- 69367-272 is the product NDC for Codeine-Guaifenesin, Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL solution, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Codeine-Guaifenesin (Codeine Phosphate and Guaifenesin).
- What is the active ingredient?
- Codeine phosphate, Guaifenesin.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Codeine-Guaifenesin?
- 5 other product NDCs are listed under this name. See all Codeine-Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Codeine-Guaifenesin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-6435 | 50090-6435-00 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Proficient Rx LP | 71205-624 | 71205-0624-04 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Method Pharmaceuticals, LLC | 58657-500 | 58657-0500-0458657-0500-16 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | NuCare Pharmaceuticals,Inc. | 68071-5173 | 68071-5173-04 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-1669 | 72162-1669-02 |
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 |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | TabletOral | KRAMER LABORATORIES | 55505-231 |
| Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients | Solution/ dropsOral | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 54859-606 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
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