Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin NDC 58657-508
Guaifenesin 100 mg/5mL · Liquid · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58657-508Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0508Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-508-16 | 58657050816 | 473 mL in 1 BOTTLE (58657-508-16)Marketed from Apr 1, 2024 |
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 58657-508_41b51a4b-65a5-778b-e063-6294a90ae4a9SPL ID 41b51a4b-65a5-778b-e063-6294a90ae4a9SPL set ID 1539c3d4-d982-7d4e-e063-6394a90ad7d6RxCUI 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
N458657050816followed by a unit qualifier and the quantityPackage 58657-0508-16. 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 58657-508
- What is NDC 58657-508?
- 58657-508 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?
- 61 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 | 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 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | TARGET CORPORATION | 11673-539 | 11673-0539-02 |
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 |
|---|---|---|---|---|
| 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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