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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IBUPROFEN SODIUM | 0573-0134-80 | Haleon US Holdings LLC | NDA201803 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0161-51 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0154-84 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 66715-9601-3 | Lil' Drug Store Products, Inc. | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN SODIUM | 0573-0133-81 | Haleon US Holdings LLC | NDA201803 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 0573-0145-72 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-1769-80 | Haleon US Holdings LLC | NDA020402 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 50580-603-04 | Johnson & Johnson Consumer Inc. | NDA020516 | HUMAN OTC DRUG | NDA |
IBUPROFEN; ACETAMINOPHEN | 0573-0147-36 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN; DIPHENHYDRAMINE CITRATE | 66715-9733-8 | Lil' Drug Store Products, Inc. | NDA021394 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0165-30 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN SODIUM | 0573-0133-20 | Haleon US Holdings LLC | NDA201803 | HUMAN OTC DRUG | NDA |
DIPHENHYDRAMINE CITRATE; IBUPROFEN | 29485-7008-3 | Lil Drug Store Products, Inc | NDA021394 | HUMAN OTC DRUG | NDA |
DIPHENHYDRAMINE CITRATE; IBUPROFEN | 0573-0164-43 | Haleon US Holdings LLC | NDA021394 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0150-40 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN; FAMOTIDINE | 75987-010-03 | Horizon Therapeutics USA, Inc. | NDA022519 | HUMAN PRESCRIPTION DRUG | NDA |
IBUPROFEN | 0573-0150-42 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 0573-0199-03 | Haleon US Holdings LLC | NDA022565 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0170-01 | Haleon US Holdings LLC | NDA020589 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 52904-794-06 | Wyeth Pharmaceuticals Company | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN; ACETAMINOPHEN | 0573-0147-95 | Haleon US Holdings LLC | NDA211733 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0150-31 | Haleon US Holdings LLC | NDA018989 | HUMAN OTC DRUG | NDA |
DIPHENHYDRAMINE CITRATE; IBUPROFEN | 0573-0164-33 | Haleon US Holdings LLC | NDA021394 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; IBUPROFEN | 67751-150-01 | Navajo Manufacturing Company Inc. | NDA022565 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0290-01 | Haleon US Holdings LLC | NDA020589 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 0573-0169-02 | Haleon US Holdings LLC | NDA020402 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 66715-9700-3 | Lil' Drug Store Products, Inc. | NDA018989 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 67751-120-02 | Navajo Manufacturing Company Inc. | NDA019012 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 67751-120-01 | Navajo Manufacturing Company Inc. | NDA019012 | HUMAN OTC DRUG | NDA |
IBUPROFEN | 67751-148-03 | Navajo Manufacturing Company Inc. | NDA020402 | HUMAN OTC DRUG | NDA |
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