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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ACETAMINOPHEN | 36800-455-62 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 36800-161-16 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 36800-667-24 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 36800-459-30 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-973-78 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 36800-301-02 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-697-04 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DOXYLAMINE SUCCINATE | 76162-823-12 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 36800-659-24 | TopCo Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 36800-096-91 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-700-53 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-522-40 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 36800-474-02 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-655-24 | TopCo Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 36800-700-73 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-484-62 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-435-15 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 36800-908-38 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-484-76 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-095-17 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN | 36800-787-02 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
CAFFEINE; ACETAMINOPHEN; ASPIRIN | 36800-934-60 | Topco Associates LLC | ANDA075794 | HUMAN OTC DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 36800-614-73 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-095-03 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-437-71 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 36800-707-34 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 36800-707-26 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-946-16 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-632-05 | TOPCO ASSOCIATES LLC | ANDA211544 | HUMAN OTC DRUG | ANDA |
DOXYLAMINE SUCCINATE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 76162-824-12 | Topco Associates LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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