Ingredient Name
|
NDC
|
Company Name
|
Application Number or Regulatory Citation
|
Product Type
|
Marketing Category
|
HYDROCODONE BITARTRATE; ACETAMINOPHEN |
27808-116-02 |
Tris Pharma Inc |
ANDA202214 |
HUMAN PRESCRIPTION DRUG |
ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN |
27808-130-01 |
Tris Pharma Inc |
ANDA201295 |
HUMAN PRESCRIPTION DRUG |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
27854-299-00 |
Belmora LLC |
M012 |
HUMAN OTC DRUG |
OTC Monograph Drug |
CAFFEINE; ACETAMINOPHEN |
27854-301-01 |
Belmora LLC |
M013 |
HUMAN OTC DRUG |
OTC Monograph Drug |
GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
27854-350-01 |
Belmora LLC |
M012 |
HUMAN OTC DRUG |
OTC Monograph Drug |
ACETAMINOPHEN |
27854-388-01 |
Belmora LLC |
part343 |
HUMAN OTC DRUG |
OTC monograph not final |
EPINEPHRINE; DIPHENHYDRAMINE HYDROCHLORIDE; ATROPINE SULFATE; ISOPROPYL ALCOHOL; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; NITROGLYCERIN; ASPIRIN; ALBUTEROL SULFATE; ACETAMINOPHEN; LIDOCAINE HYDROCHLORIDE |
27860-001-13 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
POLYMYXIN B SULFATE; MECLIZINE HYDROCHLORIDE; CALCIUM CARBONATE; AMMONIA; NEOMYCIN SULFATE; OXYMETAZOLINE HYDROCHLORIDE; BACITRACIN ZINC; LOPERAMIDE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ISOPROPYL ALCOHOL; ACETAMINOPHEN |
27860-003-09 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
MECLIZINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; POVIDONE-IODINE; ACETAMINOPHEN; CALCIUM CARBONATE; AMMONIA; PHENYLEPHRINE HYDROCHLORIDE; WATER; BISMUTH SUBSALICYLATE; BENZALKONIUM CHLORIDE |
27860-009-10 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE; CALCIUM CARBONATE; PETROLATUM; DIPHENHYDRAMINE HYDROCHLORIDE; BISMUTH SUBSALICYLATE; WATER; MINERAL OIL; ALCOHOL; AMMONIA; POVIDONE-IODINE |
27860-010-11 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
POVIDONE-IODINE; DIPHENHYDRAMINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE; ACETAMINOPHEN; WATER; PHENYLEPHRINE HYDROCHLORIDE; CALCIUM CARBONATE; LIDOCAINE HYDROCHLORIDE; MECLIZINE HYDROCHLORIDE; BISMUTH SUBSALICYLATE; AMMONIA |
27860-011-11 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
ACETAMINOPHEN; MECLIZINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIA; BISMUTH SUBSALICYLATE; BENZALKONIUM CHLORIDE; OXYMETAZOLINE HYDROCHLORIDE; POVIDONE-IODINE; CALCIUM CARBONATE |
27860-012-09 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
FUROSEMIDE; PROMETHAZINE HYDROCHLORIDE; EPINEPHRINE; DEXTROSE MONOHYDRATE; NITROGLYCERIN; HYDROCORTISONE SODIUM SUCCINATE; POVIDONE-IODINE; ACETAMINOPHEN; ASPIRIN; SODIUM CHLORIDE; ATROPINE SULFATE; DIPHENHYDRAMINE HYDROCHLORIDE; METOPROLOL TARTRATE; ALBUTEROL SULFATE; OXYTOCIN; BENZALKONIUM CHLORIDE; ISOPROPYL ALCOHOL |
27860-013-16 |
Aerospace Accessory Service, Inc |
ABC |
MEDICAL DEVICE |
exempt device |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
28623-250-01 |
Progela, S.A. de C.V. |
part341 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
28623-250-06 |
Progela, S.A. de C.V. |
part341 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
28623-250-12 |
Progela, S.A. de C.V. |
part341 |
HUMAN OTC DRUG |
OTC monograph final |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
29033-405-35 |
Nostrum Laboratories, Inc. |
ANDA201448 |
HUMAN PRESCRIPTION DRUG |
ANDA |
ACETAMINOPHEN |
29485-1887-4 |
Lil' Drug Store Products, Inc. |
M013 |
HUMAN OTC DRUG |
OTC monograph final |
CAFFEINE; ACETAMINOPHEN; PYRILAMINE MALEATE |
29485-2802-2 |
Lil' Drug Store Products, Inc. |
M013 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN |
29485-2827-8 |
Mechanical Servants, LLC |
part341 |
HUMAN OTC DRUG |
OTC monograph final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN |
29485-2828-5 |
Mechanical Servants, LLC |
part341 |
HUMAN OTC DRUG |
OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN |
29485-5043-6 |
Lil' Drug Store Products, Inc. |
M012 |
HUMAN OTC DRUG |
OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
29485-5053-6 |
Lil' Drug Store Products, Inc. |
M012 |
HUMAN OTC DRUG |
OTC monograph final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE |
29485-6486-2 |
Lil' Drug Store Products, Inc. |
M013 |
HUMAN OTC DRUG |
OTC monograph final |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
29485-6510-4 |
Lil' Drug Store Products, Inc. |
M013 |
HUMAN OTC DRUG |
OTC Monograph Drug |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
29485-6538-6 |
Lil' Drug Store Products, Inc. |
part343 |
HUMAN OTC DRUG |
OTC monograph not final |
ACETAMINOPHEN |
29485-6547-4 |
Lil' Drug Store Products, Inc. |
M013 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN |
29485-6556-4 |
Lil' Drug Store Products, Inc. |
M012 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN |
29485-6557-4 |
Lil' Drug Store Products, Inc. |
M012 |
HUMAN OTC DRUG |
OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE |
29485-6580-4 |
Lil' Drug Store Products, Inc. |
M012 |
HUMAN OTC DRUG |
OTC monograph final |