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D&C Yellow No. 10

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.

What is it?

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] [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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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