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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GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-0100-04 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-0100-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0031-0101-04 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 0031-8744-10 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-8750-12 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-8750-18 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 0031-8751-12 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 0031-8751-18 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 0031-8752-12 | Haleon US Holdings LLC | M0012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 0031-8752-18 | Haleon US Holdings LLC | M0012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0031-8770-12 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0031-8770-18 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-8771-12 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0031-8771-18 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0031-9301-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
CODEINE PHOSPHATE; CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 0054-0650-25 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE | 0054-3000-01 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 0054-3686-63 | West-Ward Pharmaceuticals Corp | ANDA089351 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 0054-4650-25 | West-Ward Pharmaceuticals Corp | ANDA087003 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 0054-4650-29 | West-Ward Pharmaceuticals Corp | ANDA087003 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 0054-8648-16 | West-Ward Pharmaceuticals Corp | ANDA089351 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 0054-8650-24 | West-Ward Pharmaceuticals Corp | ANDA087003 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0067-0100-06 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0067-0101-06 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0067-0103-06 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 0067-0104-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0067-0105-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0067-0106-06 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0067-0122-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE | 0067-0924-01 | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | HUMAN OTC DRUG | Export only |
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