D&C Red No. 28

Excipient (pharmacologically inactive substance)

What is D&C Red No. 28?

D&C Red No. 28, also known as Disodium 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (C20H2O5Br4Cl4Na2) is a dye approved by the FDA for use in drugs and cosmetics according to the specifications set forth by the FDA.[1] FD&C Red No. 28 is not approved for use in foods.

FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. These colors are then certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics.[1][2]

[1] 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

[2] 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

Top Medications Containing D&C Red No. 28

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