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; CAFFEINE; ACETAMINOPHEN | 57243-159-08 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57243-175-15 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 57243-235-15 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 57243-501-25 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 57243-502-25 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57243-506-25 | Salado Sales, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 57243-560-02 | Salado Sales, Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57344-004-04 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 57344-095-01 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 57344-095-02 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 57344-095-03 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57344-119-02 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57344-119-05 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57344-163-02 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57344-163-05 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 57344-170-01 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 57344-170-02 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 57344-170-03 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 57344-170-12 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; CAFFEINE; ASPIRIN | 57344-205-01 | AAA PHARMACEUTICAL, INC. | ANDA214039 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 57344-923-05 | AAA Pharmaceutical, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 57344-928-02 | AAA PHARMACEUTICAL, INC. | part341 | HUMAN OTC DRUG | OTC monograph final |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 57664-537-13 | Sun Pharmaceutical Industries, Inc. | ANDA077184 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 57664-537-18 | Sun Pharmaceutical Industries, Inc. | ANDA077184 | HUMAN PRESCRIPTION DRUG | ANDA |
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN | 57664-537-88 | Sun Pharmaceutical Industries, Inc. | ANDA077184 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 57896-102-01 | Geri-Care Pharmaceutical Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57896-102-05 | Geri-Care Pharmaceutical Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57896-102-10 | Geri-Care Pharmaceutical Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57896-102-20 | Geri-Care Pharmaceutical Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 57896-104-01 | Geri-Care Pharmaceutical Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
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