FDA Application
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NDC Search Results on Active Ingredient: ibuprofen
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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PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 52904-782-04 | Select Corporation | NDA022565 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 52904-782-50 | Select Corporation | NDA022565 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 0573-0199-01 | Haleon US Holdings LLC | NDA022565 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 0573-0199-22 | Haleon US Holdings LLC | NDA022565 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 0573-0199-21 | Haleon US Holdings LLC | NDA022565 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN; CHLORPHENIRAMINE MALEATE | 0573-2161-03 | Haleon US Holdings LLC | NDA022113 | HUMAN OTC DRUG | NDA |
POLYMYXIN B SULFATE; BACITRACIN ZINC; BENZALKONIUM CHLORIDE; BENZOCAINE; IBUPROFEN; ACETAMINOPHEN; ALCOHOL; NEOMYCIN SULFATE | 44224-0699-5 | Tender Corporation DBA Adventure Ready Brands | part348 | HUMAN OTC DRUG | OTC monograph final |
POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE; BENZOCAINE; IBUPROFEN; ALCOHOL; BENZALKONIUM CHLORIDE; ACETAMINOPHEN | 44224-0999-5 | Tender Corporation DBA Adventure Ready Brands | part348 | HUMAN OTC DRUG | OTC monograph final |
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC; ALCOHOL; IBUPROFEN; BENZOCAINE; ASPIRIN; BENZALKONIUM CHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 44224-2000-1 | Tender Corporation DBA Adventure Ready Brands | part333B | HUMAN OTC DRUG | OTC monograph not final |
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; LIDOCAINE HYDROCHLORIDE; BENZOCAINE; ACETAMINOPHEN; ISOPROPYL ALCOHOL; ASPIRIN; BACITRACIN ZINC; IBUPROFEN; ALCOHOL; BENZALKONIUM CHLORIDE | 52124-4002-8 | Genuine First Aid, LLC | part333B | HUMAN OTC DRUG | OTC monograph not final |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 41250-423-40 | Meijer Distribution, Inc | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 56062-423-41 | Publix Super Markets Inc | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 46084-091-60 | A P J Laboratories Limited | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 53943-423-21 | Discount Drug Mart | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 0363-1106-67 | WALGREEN CO. | ANDA209235 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 51660-423-21 | Ohm Laboratories Inc. | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 70000-0602-1 | CARDINAL HEALTH 110, LLC DBA LEADER | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 51660-423-41 | Ohm Laboratories Inc. | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 69842-092-13 | CVS Pharmacy, Inc. | ANDA209235 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 0573-0184-16 | Haleon US Holdings LLC | NDA021374 | HUMAN OTC DRUG | NDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 69842-092-67 | CVS Pharmacy, Inc. | ANDA209235 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 49348-097-47 | Sunmark | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 0363-1106-08 | WALGREEN CO. | ANDA209235 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 56062-423-21 | Publix Super Markets Inc | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 68016-423-21 | Chain Drug Consortium, LLC. | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 37808-324-40 | HEB | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 63868-453-20 | Chain Drug Marketing Association Inc. | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 30142-423-41 | The Kroger Company | ANDA074567 | HUMAN OTC DRUG | ANDA |
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN | 0573-0184-32 | Haleon US Holdings LLC | NDA021374 | HUMAN OTC DRUG | NDA |
SALICYLIC ACID; IBUPROFEN; CIMETIDINE | 72934-1047-2 | Sincerus Florida, LLC | HUMAN PRESCRIPTION DRUG | unapproved drug other |
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