Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by One2zee Limited Liability Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Doxylamine Succinate.
| Product ID | 55629-016_565b9a99-fa8f-47de-bf6a-6496657b56d4 |
| NDC | 55629-016 |
| Product Type | Human Otc Drug |
| Proprietary Name | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate |
| Generic Name | Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-03-02 |
| Marketing Category | OTC MONOGRAPH FINAL / |
| Application Number | part341 |
| Labeler Name | ONE2ZEE LIMITED LIABILITY COMPANY |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-03-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 55629-016 | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate |
| 63940-123 | Cold and Flu | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate |
| 63940-124 | Cold and Flu | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate |
| 67091-204 | Cold and Flu Relief | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |
| 67091-309 | Cold and Flu Relief | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |
| 69842-920 | Cold and Flu Relief | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |
| 0363-4670 | Daytime Nighttime Cold and Cough | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |
| 41520-446 | DayTime NiteTime Cold Flu Relief | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |
| 15127-902 | Daytime/Nighttime Cold and Flu | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate |