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 | 36800-557-28 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 76162-000-26 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-335-38 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 36800-903-26 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-900-02 | TopCo Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 36800-925-02 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-770-05 | TopCo Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 76162-732-24 | TOPCO ASSOCIATES LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-484-90 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-699-28 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-590-16 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-770-03 | TopCo Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-632-01 | TOPCO ASSOCIATES LLC | ANDA211544 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 36800-922-01 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 36800-597-02 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 36800-143-73 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-557-26 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 76162-142-01 | Topco Associates LLC | 505G(a)(3) | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 36800-594-40 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 36800-848-24 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 36800-964-91 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; IBUPROFEN | 76162-501-16 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 36800-202-34 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 36800-533-78 | Topco Associates LLC | ANDA075794 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 36800-628-02 | TOPCO ASSOCIATES LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-632-03 | TOPCO ASSOCIATES LLC | ANDA211544 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 36800-412-04 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-632-02 | TOPCO ASSOCIATES LLC | ANDA211544 | HUMAN OTC DRUG | ANDA |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 36800-775-02 | TopCo Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 36800-202-28 | Topco Associates LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
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