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US Food and Drug Administration (FDA) - Inactive Ingredients

FDA Inactive Ingredients - Updated May 2006

What is the purpose of the Inactive Ingredients Database?

The Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.
FDA Devices
FDA Inactive Ingredients
FDA Inactive Ingredients
FDA Inactive Ingredients


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Inactive Ingredient Route / Dosage Form
DYE FDC RED #40 ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC RED #40 ORAL; CAPSULE, EXTENDED RELEASE
DYE FDC RED #40 ORAL; CAPSULE, HARD GELATIN
DYE FDC RED #40 ORAL; CAPSULE, SOFT GELATIN
DYE FDC RED #40 ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #40 ORAL; CONCENTRATE
DYE FDC RED #40 ORAL; DROPS
DYE FDC RED #40 ORAL; POWDER
DYE FDC RED #40 ORAL; POWDER, FOR ORAL SUSPENSION
DYE FDC RED #40 ORAL; POWDER, FOR RECONSTITUTION
DYE FDC RED #40 ORAL; POWDER, FOR SOLUTION
DYE FDC RED #40 ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #40 ORAL; SOLUTION
DYE FDC RED #40 ORAL; SOLUTION, ELIXIR
DYE FDC RED #40 ORAL; SUSPENSION
DYE FDC RED #40 ORAL; SUSPENSION, DROPS
DYE FDC RED #40 ORAL; SUSPENSION, LIQUID
DYE FDC RED #40 ORAL; SYRUP
DYE FDC RED #40 ORAL; TABLET
DYE FDC RED #40 ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC RED #40 ORAL; TABLET, COATED
DYE FDC RED #40 ORAL; TABLET, DELAYED ACTION
DYE FDC RED #40 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC RED #40 ORAL; TABLET, FILM COATED
DYE FDC RED #40 ORAL; TABLET, SUSTAINED ACTION
DYE FDC RED #40 ORAL; TABLET, SUSTAINED ACTION, COATED
DYE FDC RED #40 ORAL-21; TABLET
DYE FDC RED #40 ORAL-28; TABLET
DYE FDC RED #40 SUBLINGUAL; TABLET
DYE FDC RED #40 TOPICAL; SHAMPOO
DYE FDC RED #40 TOPICAL; SOLUTION
DYE FDC RED #40 TOPICAL; SPONGE
DYE FDC RED #40 AC LAKE ORAL; CAPSULE
DYE FDC RED #40 LAKE ORAL; CAPSULE
DYE FDC RED #40 LAKE ORAL; CAPSULE, SOFT GELATIN
DYE FDC RED #40 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #40 LAKE ORAL; POWDER
DYE FDC RED #40 LAKE ORAL; POWDER, FOR ORAL SUSPENSION
DYE FDC RED #40 LAKE ORAL; POWDER, FOR SOLUTION
DYE FDC RED #40 LAKE ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #40 LAKE ORAL; SOLUTION
DYE FDC RED #40 LAKE ORAL; SUSPENSION
DYE FDC RED #40 LAKE ORAL; TABLET
DYE FDC RED #40 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC RED #40 LAKE ORAL; TABLET, COATED
DYE FDC RED #40 LAKE ORAL; TABLET, EXTENDED RELEASE
DYE FDC RED #40 LAKE ORAL; TABLET, FILM COATED
DYE FDC RED #40 LAKE ORAL; TABLET, SUSTAINED ACTION
DYE FDC RED #40 LAKE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
DYE FDC RED #40 LAKE ORAL-28; TABLET
DYE FDC RED #40 LAKE SUBLINGUAL; TABLET
DYE FDC RED #7 LAKE ORAL; CAPSULE
DYE FDC RED #7 LAKE ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #7 LAKE ORAL; TABLET
DYE FDC VIOLET #1 ORAL; TABLET
DYE FDC VIOLET #1 ORAL; TABLET, COATED
DYE FDC VIOLET #1 LAKE ORAL; TABLET
DYE FDC YELLOW #1 ORAL; TABLET
DYE FDC YELLOW #10 ORAL; CAPSULE
DYE FDC YELLOW #10 ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC YELLOW #10 ORAL; POWDER, FOR SOLUTION
DYE FDC YELLOW #10 ORAL; SUSPENSION
DYE FDC YELLOW #10 ORAL; SYRUP
DYE FDC YELLOW #10 ORAL; TABLET
DYE FDC YELLOW #10 ORAL; TABLET, COATED
DYE FDC YELLOW #10 ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #10 ORAL-28; TABLET
DYE FDC YELLOW #10 TOPICAL; LOTION
DYE FDC YELLOW #10 LAKE ORAL; CAPSULE
DYE FDC YELLOW #10 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC YELLOW #10 LAKE ORAL; SOLUTION, ELIXIR
DYE FDC YELLOW #10 LAKE ORAL; TABLET
DYE FDC YELLOW #10 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC YELLOW #10 LAKE ORAL; TABLET, FILM COATED
DYE FDC YELLOW #10 LAKE ORAL-21; TABLET
DYE FDC YELLOW #10 LAKE ORAL-28; TABLET
DYE FDC YELLOW #10 LAKE SUBLINGUAL; TABLET
DYE FDC YELLOW #3 ORAL; TABLET
DYE FDC YELLOW #5 BUCCAL/SUBLINGUAL; TABLET
DYE FDC YELLOW #5 ORAL; CAPSULE
DYE FDC YELLOW #5 ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC YELLOW #5 ORAL; CAPSULE, SOFT GELATIN
DYE FDC YELLOW #5 ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC YELLOW #5 ORAL; SOLUTION
DYE FDC YELLOW #5 ORAL; SOLUTION, ELIXIR
DYE FDC YELLOW #5 ORAL; SUSPENSION
DYE FDC YELLOW #5 ORAL; SYRUP
DYE FDC YELLOW #5 ORAL; TABLET
DYE FDC YELLOW #5 ORAL; TABLET, COATED
DYE FDC YELLOW #5 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC YELLOW #5 ORAL; TABLET, FILM COATED
DYE FDC YELLOW #5 ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #5 ORAL; TABLET, SUSTAINED ACTION, COATED
DYE FDC YELLOW #5 ORAL-20; TABLET
DYE FDC YELLOW #5 TOPICAL; EMULSION, CREAM
DYE FDC YELLOW #5 TOPICAL; POWDER
DYE FDC YELLOW #5 TOPICAL; SHAMPOO, SUSPENSION
DYE FDC YELLOW #5 TOPICAL; SOLUTION
DYE FDC YELLOW #5 VAGINAL; EMULSION, CREAM
DYE FDC YELLOW #5 VAGINAL; SUPPOSITORY

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Last Modified: 29 April 2006
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