Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin NDC 58657-509
Guaifenesin 100 mg/5mL · Liquid · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58657-509Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0509Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-509-16 | 58657050916 | 473 mL in 1 BOTTLE (58657-509-16)Marketed from Feb 9, 2016 |
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)
- Guaifenesin
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 100 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 58657-509_41b52068-d18f-5c54-e063-6394a90aa503SPL ID 41b52068-d18f-5c54-e063-6394a90aa503SPL set ID 312ce620-4841-7488-e054-00144ff88e88RxCUI 310604UNII 495W7451VQ
- Pharmacologic class
- Expectorant
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
N458657050916followed by a unit qualifier and the quantityPackage 58657-0509-16. 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 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Excerpt only. Read the full label for complete information.
About NDC 58657-509
- What is NDC 58657-509?
- 58657-509 is the product NDC for Guaifenesin, Guaifenesin 100 mg/5mL liquid, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin.
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. 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?
- 62 other product NDCs are listed under this name. See all Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 200 mg/1 | TabletOral | Zennova LLC | 81993-002 | 81993-0002-0181993-0002-0281993-0002-03+2 more |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 | 76162-0031-56 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 | 73581-0400-0273581-0400-07 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 | 68196-0960-56 |
| Guaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | KESIN PHARMA CORPORATION | 81033-102 | 81033-0102-16 |
| Guaifenesin | Guaifenesin 100 mg/5mL | SolutionOral | American Health Packaging | 60687-852 | 60687-0852-17 |
| Guaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | American Health Packaging | 60687-863 | 60687-0863-56 |
| Guaifenesin | Guaifenesin 300 mg/15mL | SolutionOral | American Health Packaging | 60687-874 | 60687-0874-16 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | GRANULES USA, INC. | 69848-018 | 69848-0018-16 |
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 |
|---|---|---|---|---|
| Nighttime Cold and Flu Multi Symptom Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0177 |
| Revasol Acetaminophen Suspensionacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Rnv LLC | 84379-311 |
| Curewell Tussin DMdextromethorphan, guaifenesin | Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL | LiquidOral | RMT HEALTH LLC | 85111-802 |
| Sinus Congestion and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | Rugby Laboratories | 0536-1289 |
| Dometusschlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Domel Laboratories | 53809-222 |
| Night Time Multi-Symptom Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Discount Drug Mart | 53943-603 |
| GeriCare Tussin DM Maxdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | LiquidOral | GERI-CARE PHARMACEUTICALS, CORP | 57896-591 |
| Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesin | Guaifenesin 100 mg/5mL; Dextromethorphan hydrobromide 10 mg/5mL | SolutionOral | Gil Pharmaceutical Corp | 58552-141 |
| Mucinex Childrens Coughdextromethorphan hydrobromide and guaifenesin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Reckitt Benckiser LLC | 63824-946 |
| Tussin Cough DM Sugar Freedextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-869 |
| Allergy Sinus, Lil Drug Storeacetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | Lil' Drug Store Products, Inc. | 66715-9927 |
| Daytime Cold and Flu Maximum Strengthacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0178 |
| Sinus Decongestionpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Kroger Company | 30142-641 |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0166 |
| Mucus Relief Sinus Severe Congestion and Painacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | AMERISOURCE BERGEN | 46122-712 |
| CVS Health Sinusoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CVS PHARMACY, INC. | 69842-715 |
| CVS PHARMACY Childrens Cold and Allergybrompheniramine maleate | Brompheniramine maleate 2 mg/10mL | LiquidOral | CVS PHARMACY, INC. | 51316-693 |
| The Original Natural Herb Cough Dropsmenthol | Menthol 4.8 mg/1 | LozengeOral | Ricola Ag | 54305-175 |
| Sinus Pressure and Painacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | Family Dollar Services Inc | 55319-702 |
| Giltuss Severe Sinusoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Gil Pharmaceutical Corp | 58552-142 |
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