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NDC 58657-0505-08 Guaifenesin and Dextromethorphan Hydrobromide 10; 100 mg/5mL; mg/5mL Details
Guaifenesin and Dextromethorphan Hydrobromide 10; 100 mg/5mL; mg/5mL
Guaifenesin and Dextromethorphan Hydrobromide is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Method Pharmaceuticals. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 58657-0505-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 58657-0505-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 58657-0505 |
|---|---|
| Product ID | 58657-505_0c5adf4a-963a-2810-e063-6394a90aed54 |
| Associated GPIs | 43997002521220 |
| GCN Sequence Number | 016414 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan SYRUP 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53495 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Method Pharmaceuticals |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58657-0505-08 (58657050508)
| NDC Package Code | 58657-505-08 |
|---|---|
| Billing NDC | 58657050508 |
| Package | 237 mL in 1 BOTTLE, PLASTIC (58657-505-08) |
| Marketing Start Date | 2016-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03072 |
| Pricing Unit | ML |
| Effective Date | 2023-12-20 |
| NDC Description | GUAIFENESIN-DM 100-10 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |