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

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