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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DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 36800-757-72 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 36800-459-34 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-961-20 | TOPCO ASSOCIATES LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE | 36800-763-34 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 76162-050-45 | TOPCO ASSOCIATES LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-455-79 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; ASPIRIN | 36800-675-20 | TOPCO ASSOCIATES LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; IBUPROFEN | 76162-501-68 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-521-05 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-484-71 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-699-26 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-779-47 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 36800-228-01 | Topco Associates LLC | ANDA076200 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 36800-973-71 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-369-78 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-522-34 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-410-04 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-335-34 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-770-02 | TopCo Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ACETAMINOPHEN; ASPIRIN | 36800-675-10 | TOPCO ASSOCIATES LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-335-30 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 36800-986-24 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-593-73 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-455-71 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 36800-202-26 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-946-10 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 36800-581-62 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-484-78 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 36800-914-02 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 36800-765-12 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
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