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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ASPIRIN; POLYMYXIN B SULFATE; ACETAMINOPHEN; LIDOCAINE HYDROCHLORIDE; NEOMYCIN SULFATE; ISOPROPYL ALCOHOL; CALCIUM CARBONATE; BACITRACIN ZINC; BENZALKONIUM CHLORIDE | 65517-0021-1 | Dukal LLC | part333 | MEDICAL DEVICE | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 55316-012-14 | DZA Brands LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 55316-013-14 | DZA Brands LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 68737-225-09 | EAGLE DISTRIBUTORS, INC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 68737-224-08 | EAGLE DISTRIBUTORS, INC. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN | 68737-226-10 | EAGLE DISTRIBUTORS, INC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 68737-227-11 | EAGLE DISTRIBUTORS, INC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 68737-231-15 | Eagle Distributors,Inc | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 68737-238-22 | Eagle Distributors,Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68737-239-23 | Eagle Distributors,Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 68737-235-19 | Eagle Distributors,Inc. | part338 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 68737-236-20 | Eagle Distributors,Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 68737-234-18 | Eagle Distributors,Inc. | part343 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 68737-240-24 | Eagle Distributors,Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68737-232-16 | Eagle Distributors,Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 68737-233-17 | Eagle Distributors,Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 83174-613-26 | Easyfast Supplements LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0485-0057-08 | EDWARDS PHARMACEUTICALS, INC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 58593-830-06 | EFFICIENT LABORATORIES INC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 58593-828-08 | EFFICIENT LABORATORIES INC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; BUTALBITAL | 11584-0030-1 | El Dorado Distributors LLC | ANDA089987 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 64850-641-12 | Elite Laboratories, Inc. | ANDA212418 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 64850-642-12 | Elite Laboratories, Inc. | ANDA212418 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE | 64850-643-12 | Elite Laboratories, Inc. | ANDA212418 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 80272-002-04 | Ellywell, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 63481-627-70 | Endo Pharmaceuticals Inc. | ANDA040330 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 63481-629-70 | Endo Pharmaceuticals Inc. | ANDA040330 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 63481-628-70 | Endo Pharmaceuticals Inc. | ANDA040330 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 63481-623-85 | Endo Pharmaceuticals Inc. | ANDA040330 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 63481-623-70 | Endo Pharmaceuticals Inc. | ANDA040330 | HUMAN PRESCRIPTION DRUG | ANDA |
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