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NDC 63824-0214-64 Childrens Delsym 5; 100 mg/5mL; mg/5mL Details
Childrens Delsym 5; 100 mg/5mL; mg/5mL
Childrens Delsym is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. 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: 63824-0214-64Last 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: 63824-0214-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 63824-0214 |
|---|---|
| Product ID | 63824-214_f5770e3a-85d9-c525-e053-2a95a90a936c |
| Associated GPIs | 43997002520905 |
| GCN Sequence Number | 023893 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-5 MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53497 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Childrens Delsym |
| Proprietary Name Suffix | Cough Plus Chest Congestion DM |
| Non-Proprietary Name | Dextromethorphan Hydrobromide and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | RB Health (US) LLC |
| 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 FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63824-0214-64 (63824021464)
| NDC Package Code | 63824-214-64 |
|---|---|
| Billing NDC | 63824021464 |
| Package | 1 BOTTLE in 1 CARTON (63824-214-64) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2017-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.05942 |
| Pricing Unit | ML |
| Effective Date | 2023-12-20 |
| NDC Description | CHILD DELSYM COUGH-CHEST DM LQ |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5, 6 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |