FDA Application
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NDC Search Results on Active Ingredient: acetaminophen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
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CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-01 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-02 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-04 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-10 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-20 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-010-50 | MIDWAY IMPORTING INC. | M012 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76095-011-20 | Midway Importing, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 76162-000-26 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 76162-000-34 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 76162-026-16 | TopCo Associates, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 76162-050-45 | TOPCO ASSOCIATES LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76162-065-16 | TopCo Associates, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 76162-079-36 | TOPCO ASSOCIATES LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 76162-142-01 | Topco Associates LLC | 505G(a)(3) | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 76162-202-40 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 76162-500-40 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; IBUPROFEN | 76162-501-16 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 76162-501-23 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; IBUPROFEN | 76162-501-68 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
IBUPROFEN; ACETAMINOPHEN | 76162-520-23 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 76162-720-24 | TOPCO ASSOCIATES LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 76162-732-24 | TOPCO ASSOCIATES LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 76162-811-24 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 76162-812-24 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DOXYLAMINE SUCCINATE | 76162-823-12 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76162-824-12 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 76168-010-12 | Velocity Pharma | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 76168-011-04 | Velocity Pharma | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 76168-021-13 | Velocity Pharma | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 76168-055-02 | Velocity Pharma | part341 | HUMAN OTC DRUG | OTC monograph final |
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