Over-the-counter drug · OTC MONOGRAPH DRUG
Guaifenesin DM (Guaifenesin and dextromethorphan) NDC 60687-817
Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL · Syrup · Oral · American Health Packaging
NDC codes
FDA NDC DirectoryProduct NDC (as listed)60687-817Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0817Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-817-17 | 60687081717 | 10 TRAY in 1 CASE (60687-817-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-817-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-817-40)Marketed from Aug 4, 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 DM
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan
- Active ingredients
- Guaifenesin — 100 mg/5mLDextromethorphan — 10 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- 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)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 60687-817_1d755574-97e5-8933-e063-6294a90a1e61SPL ID 1d755574-97e5-8933-e063-6294a90a1e61SPL set ID 990906b3-c566-4f35-923c-060202ba48e0RxCUI 996520UNII 495W7451VQ, 7355X3ROTS
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N460687081717followed by a unit qualifier and the quantityPackage 60687-0817-17. 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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Excerpt only. Read the full label for complete information.
About NDC 60687-817
- What is NDC 60687-817?
- 60687-817 is the product NDC for Guaifenesin DM, Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL syrup, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin DM (Guaifenesin and Dextromethorphan).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan.
- Who is the labeler?
- American Health Packaging, NDC labeler code 60687. 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 DM?
- 7 other product NDCs are listed under this name. See all Guaifenesin DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin DM 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 DMdextromethorphan hydrobromide,guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Innovida Pharmaeutique Corporation | 71800-057 | 71800-0057-05 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL | SyrupOral | American Health Packaging | 60687-828 | 60687-0828-56 |
| Guaifenesin DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-801 | 43063-0801-3043063-0801-6043063-0801-90 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | PAI Holdings, LLC dba PAI Pharma | 0121-0638 | 00121-0638-0000121-0638-0400121-0638-08+1 more |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 200 mg/10mL; Dextromethorphan 20 mg/10mL | SyrupOral | PAI Holdings, LLC dba PAI Pharma | 0121-1276 | 00121-1276-00 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | Cardinal Health 107, LLC | 55154-5783 | 55154-5783-05 |
| Guaifenesin DMguaifenesin and dextromethorphan | Guaifenesin 100 mg/5mL; Dextromethorphan 10 mg/5mL | SyrupOral | Cardinal Health 107, LLC | 55154-5785 | 55154-5785-05 |
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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