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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 DC RED #40 ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #40 ORAL; TABLET
DYE DC RED #40 LAKE ORAL; CAPSULE
DYE DC RED #40 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #40 LAKE ORAL; TABLET
DYE DC RED #40 LAKE ORAL; TABLET, COATED
DYE DC RED #40 LAKE RECTAL; SUPPOSITORY
DYE DC RED #5 ORAL; TABLET
DYE DC RED #6 ORAL; TABLET, COATED
DYE DC RED #6 BARIUM LAKE ORAL; TABLET
DYE DC RED #6 LAKE ORAL; TABLET
DYE DC RED #7 ORAL; TABLET
DYE DC RED #7 ORAL; TABLET, COATED
DYE DC RED #7 ORAL; TABLET, FILM COATED
DYE DC RED #7 CALCIUM LAKE ORAL; CAPSULE
DYE DC RED #7 CALCIUM LAKE ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC RED #7 CALCIUM LAKE ORAL; CAPSULE, HARD GELATIN
DYE DC RED #7 CALCIUM LAKE ORAL; TABLET
DYE DC RED #7 CALCIUM LAKE ORAL; TABLET, COATED
DYE DC RED #7 CALCIUM LAKE ORAL; TABLET, FILM COATED
DYE DC RED #7 CALCIUM LAKE ORAL; TABLET, SUSTAINED ACTION
DYE DC RED #7 CALCIUM LAKE SUBLINGUAL; TABLET
DYE DC RED #7 LAKE ORAL; TABLET
DYE DC RED #7 LAKE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE DC RED #7 LAKE ORAL; TABLET, FILM COATED
DYE DC RED LAKE ORAL; TABLET
DYE DC RED LB #9570 ORAL; TABLET
DYE DC RED LB WJ-9570 ORAL; TABLET
DYE DC VIOLET #2 LAKE ORAL; TABLET
DYE DC YELLOW #10 BUCCAL; GUM, CHEWING
DYE DC YELLOW #10 DENTAL; GEL
DYE DC YELLOW #10 DENTAL; PASTE
DYE DC YELLOW #10 INHALATION; SOLUTION
DYE DC YELLOW #10 ORAL; CAPSULE
DYE DC YELLOW #10 ORAL; CAPSULE (IMMED./COMP. RELEASE), SOFT GELATIN, PERLE
DYE DC YELLOW #10 ORAL; CAPSULE, COATED PELLETS
DYE DC YELLOW #10 ORAL; CAPSULE, COATED, SOFT GELATIN
DYE DC YELLOW #10 ORAL; CAPSULE, DELAYED ACTION
DYE DC YELLOW #10 ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC YELLOW #10 ORAL; CAPSULE, HARD GELATIN
DYE DC YELLOW #10 ORAL; CAPSULE, SOFT GELATIN
DYE DC YELLOW #10 ORAL; CAPSULE, SUSTAINED ACTION
DYE DC YELLOW #10 ORAL; CONCENTRATE
DYE DC YELLOW #10 ORAL; POWDER
DYE DC YELLOW #10 ORAL; SOLUTION
DYE DC YELLOW #10 ORAL; SOLUTION, ELIXIR
DYE DC YELLOW #10 ORAL; SOLUTION, LIQUID
DYE DC YELLOW #10 ORAL; SUSPENSION
DYE DC YELLOW #10 ORAL; SUSPENSION, DROPS
DYE DC YELLOW #10 ORAL; SUSPENSION, LIQUID
DYE DC YELLOW #10 ORAL; SUSPENSION, SUSTAINED ACTION
DYE DC YELLOW #10 ORAL; SYRUP
DYE DC YELLOW #10 ORAL; TABLET
DYE DC YELLOW #10 ORAL; TABLET, COATED
DYE DC YELLOW #10 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE DC YELLOW #10 ORAL; TABLET, EXTENDED RELEASE
DYE DC YELLOW #10 ORAL; TABLET, FILM COATED
DYE DC YELLOW #10 ORAL; TABLET, SUSTAINED ACTION
DYE DC YELLOW #10 ORAL-21; TABLET
DYE DC YELLOW #10 ORAL-28; TABLET
DYE DC YELLOW #10 RECTAL; SOLUTION
DYE DC YELLOW #10 RECTAL; SUPPOSITORY
DYE DC YELLOW #10 SUBLINGUAL; TABLET
DYE DC YELLOW #10 TOPICAL; EMULSION, CREAM
DYE DC YELLOW #10 TOPICAL; LOTION
DYE DC YELLOW #10 TOPICAL; SHAMPOO
DYE DC YELLOW #10 TOPICAL; SHAMPOO, SUSPENSION
DYE DC YELLOW #10 HT LAKE ORAL; TABLET
DYE DC YELLOW #10 HT LAKE ORAL; TABLET, SUSTAINED ACTION
DYE DC YELLOW #10 LAKE BUCCAL; GUM, CHEWING
DYE DC YELLOW #10 LAKE ORAL; CAPSULE
DYE DC YELLOW #10 LAKE ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC YELLOW #10 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE DC YELLOW #10 LAKE ORAL; POWDER
DYE DC YELLOW #10 LAKE ORAL; POWDER, FOR SUSPENSION
DYE DC YELLOW #10 LAKE ORAL; TABLET
DYE DC YELLOW #10 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC YELLOW #10 LAKE ORAL; TABLET, COATED
DYE DC YELLOW #10 LAKE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE DC YELLOW #10 LAKE ORAL; TABLET, DISPERSIBLE
DYE DC YELLOW #10 LAKE ORAL; TABLET, EXTENDED RELEASE
DYE DC YELLOW #10 LAKE ORAL; TABLET, FILM COATED
DYE DC YELLOW #10 LAKE ORAL; TABLET, REPEAT ACTION
DYE DC YELLOW #10 LAKE ORAL; TABLET, SUSTAINED ACTION
DYE DC YELLOW #10 LAKE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
DYE DC YELLOW #10 LAKE ORAL; TABLET, SUSTAINED RELEASE, FILM COATED
DYE DC YELLOW #10 LAKE ORAL-21; TABLET
DYE DC YELLOW #10 LAKE ORAL-28; TABLET
DYE DC YELLOW #10 LAKE SUBLINGUAL; TABLET
DYE DC YELLOW #5 ORAL; TABLET
DYE DC YELLOW #5 SUBLINGUAL; TABLET
DYE DC YELLOW #5 LAKE ORAL; TABLET
DYE DC YELLOW #5 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC YELLOW #5 LAKE ORAL; TABLET, FILM COATED
DYE DC YELLOW #6 ORAL; CAPSULE
DYE DC YELLOW #6 ORAL; CAPSULE, SUSTAINED ACTION
DYE DC YELLOW #6 ORAL; POWDER, FOR SUSPENSION
DYE DC YELLOW #6 ORAL; TABLET
DYE DC YELLOW #6 ORAL-21; TABLET
DYE DC YELLOW #6 LAKE ORAL; CAPSULE

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Last Modified: 29 April 2006
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