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FD&C Red No. 4

Medically reviewed by Last updated on May 29, 2023.

Excipient (pharmacologically inactive substance)

What is it?

FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Red No. 4 may be safely used in externally applied drugs and cosmetics in amounts consistent with good manufacturing practice. All batches of FD&C Red No. 4 shall be certified in accordance with regulations as set forth by the FDA.[1][2]

List of medications using FD&C Red No. 4


  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.;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.;idno=21;cc=ecfr#21:
  2. U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011.

Further information

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