D&C Yellow No. 10
Excipient (pharmacologically inactive substance)
What is D&C Yellow No. 10?
FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Yellow # 10 (2-(2-Quinolyl)-1,3-indandione disulfonic acid disodium salt) is a FDA-approved colorant commonly used to color dose forms such as tablets and capsules. FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry.The FDA states that D&C Yellow No. 10 may be safely used as a colorant. D&C Yellow No. 10 is approved for use in drugs and cosmetics but is not approved as a colorant for food.[1] [2]
[1] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35
[2] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm
Top Medications Containing D&C Yellow No. 10
- Acetaminophen and Propoxyphene Napsylate 650 mg / 100 mg (Teva Pharmaceuticals USA)
- Amitriptyline Hydrochloride 25 mg (Mylan Pharmaceuticals Inc.)
- Clonazepam 1 mg (Actavis)
- Clonazepam 1 mg (Mylan Pharmaceuticals Inc.)
- Clonazepam 0.5 mg (Mylan Pharmaceuticals Inc.)
- Clonazepam 1 mg (Teva Pharmaceuticals USA)
- Clonazepam 0.5 mg (Teva Pharmaceuticals USA)
- Cyclobenzaprine Hydrochloride 10 mg (Qualitest Pharmaceuticals Inc.)
- Cyclobenzaprine Hydrochloride 10 mg (Teva Pharmaceuticals)
- Cyclobenzaprine Hydrochloride 10 mg (Amneal Pharmaceuticals)
- Diazepam 10 mg (Mylan Pharmaceuticals Inc.)
- Diazepam 5 mg (Watson Laboratories, Inc.)
- Dilaudid 4 mg (Purdue Pharma LP)
- Endocet 325 mg / 10 mg (Endo Pharmaceuticals Inc.)
- Endocet 650 mg / 10 mg (Endo Pharmaceuticals Inc.)
- HydrOXYzine Pamoate 25 mg (Sandoz Pharmaceuticals Inc.)
- Meclizine Hydrochloride 25 mg (Par Pharmaceutical Inc.)
- Oxycodone Hydrochloride 15 mg (Actavis)
- Oxycodone Hydrochloride 15 mg (Qualitest Pharmaceuticals Inc.)
- Oxycodone Hydrochloride 15 mg (Mallinckrodt Pharmaceuticals)
