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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 YELLOW #6 LAKE ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC YELLOW #6 LAKE ORAL; SOLUTION
DYE DC YELLOW #6 LAKE ORAL; TABLET
DYE DC YELLOW #6 LAKE ORAL; TABLET, COATED
DYE DC YELLOW #6 LAKE ORAL; TABLET, FILM COATED
DYE DC YELLOW #6 LAKE SUBLINGUAL; TABLET
DYE DIOLACK 00F32892 YELLOW ORAL; TABLET
DYE EMERALD GREEN LB ORAL; TABLET
DYE EMERALD GREEN LB-9207 ORAL; TABLET
DYE FDC BLACK LB260 ORAL; TABLET
DYE FDC BLUE #1 DENTAL; PASTE
DYE FDC BLUE #1 DENTAL; SOLUTION
DYE FDC BLUE #1 ORAL; BAR, CHEWABLE
DYE FDC BLUE #1 ORAL; CAPSULE
DYE FDC BLUE #1 ORAL; CAPSULE, COATED PELLETS
DYE FDC BLUE #1 ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC BLUE #1 ORAL; CAPSULE, EXTENDED RELEASE
DYE FDC BLUE #1 ORAL; CAPSULE, HARD GELATIN
DYE FDC BLUE #1 ORAL; CAPSULE, SOFT GELATIN
DYE FDC BLUE #1 ORAL; CAPSULE, SOFT GELATIN LIQUID-FILLED
DYE FDC BLUE #1 ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC BLUE #1 ORAL; CONCENTRATE
DYE FDC BLUE #1 ORAL; POWDER, FOR SUSPENSION
DYE FDC BLUE #1 ORAL; SOLUTION
DYE FDC BLUE #1 ORAL; SOLUTION, ELIXIR
DYE FDC BLUE #1 ORAL; SUSPENSION
DYE FDC BLUE #1 ORAL; SUSPENSION, LIQUID
DYE FDC BLUE #1 ORAL; SUSPENSION, SUSTAINED ACTION
DYE FDC BLUE #1 ORAL; SYRUP
DYE FDC BLUE #1 ORAL; TABLET
DYE FDC BLUE #1 ORAL; TABLET, COATED
DYE FDC BLUE #1 ORAL; TABLET, DELAYED ACTION
DYE FDC BLUE #1 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC BLUE #1 ORAL; TABLET, FILM COATED
DYE FDC BLUE #1 ORAL; TABLET, SUSTAINED ACTION
DYE FDC BLUE #1 ORAL; TABLET, SUSTAINED ACTION, COATED
DYE FDC BLUE #1 ORAL-21; TABLET
DYE FDC BLUE #1 ORAL-28; TABLET
DYE FDC BLUE #1 RECTAL; SOLUTION
DYE FDC BLUE #1 SUBLINGUAL; TABLET
DYE FDC BLUE #1 TOPICAL; LOTION
DYE FDC BLUE #1 TOPICAL; SHAMPOO
DYE FDC BLUE #1 TOPICAL; SHAMPOO, SUSPENSION
DYE FDC BLUE #1 TOPICAL; SWAB
DYE FDC BLUE #1 H.T. ALUMINUM LAKE ORAL; CAPSULE
DYE FDC BLUE #1 H.T. ALUMINUM LAKE ORAL; TABLET
DYE FDC BLUE #1 H.T. ALUMINUM LAKE ORAL-28; TABLET
DYE FDC BLUE #1 LAKE INTRAUTERINE; INTRAUTERINE DEVICE
DYE FDC BLUE #1 LAKE ORAL; CAPSULE
DYE FDC BLUE #1 LAKE ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC BLUE #1 LAKE ORAL; CAPSULE, HARD GELATIN
DYE FDC BLUE #1 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC BLUE #1 LAKE ORAL; POWDER, FOR SOLUTION
DYE FDC BLUE #1 LAKE ORAL; SYRUP
DYE FDC BLUE #1 LAKE ORAL; TABLET
DYE FDC BLUE #1 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC BLUE #1 LAKE ORAL; TABLET, COATED
DYE FDC BLUE #1 LAKE ORAL; TABLET, CONTROLLED RELEASE
DYE FDC BLUE #1 LAKE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC BLUE #1 LAKE ORAL; TABLET, EXTENDED RELEASE
DYE FDC BLUE #1 LAKE ORAL; TABLET, FILM COATED
DYE FDC BLUE #1 LAKE ORAL; TABLET, SUSTAINED ACTION
DYE FDC BLUE #1 LAKE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
DYE FDC BLUE #1 LAKE ORAL-28; TABLET
DYE FDC BLUE #10 ORAL; SYRUP
DYE FDC BLUE #10 ORAL; TABLET
DYE FDC BLUE #2 BUCCAL; TABLET
DYE FDC BLUE #2 ORAL; CAPSULE
DYE FDC BLUE #2 ORAL; CAPSULE, DELAYED ACTION
DYE FDC BLUE #2 ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC BLUE #2 ORAL; CAPSULE, EXTENDED RELEASE
DYE FDC BLUE #2 ORAL; CAPSULE, HARD GELATIN
DYE FDC BLUE #2 ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC BLUE #2 ORAL; TABLET
DYE FDC BLUE #2 ORAL; TABLET, COATED
DYE FDC BLUE #2 ORAL; TABLET, CONTROLLED RELEASE
DYE FDC BLUE #2 ORAL; TABLET, DELAYED ACTION
DYE FDC BLUE #2 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC BLUE #2 ORAL; TABLET, FILM COATED
DYE FDC BLUE #2 ORAL; TABLET, SUSTAINED ACTION
DYE FDC BLUE #2 ORAL; TABLET, SUSTAINED ACTION, COATED
DYE FDC BLUE #2 ORAL-28; TABLET
DYE FDC BLUE #2 HT LAKE ORAL; TABLET
DYE FDC BLUE #2 LAKE ORAL; CAPSULE
DYE FDC BLUE #2 LAKE ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC BLUE #2 LAKE ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC BLUE #2 LAKE ORAL; TABLET
DYE FDC BLUE #2 LAKE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC BLUE #2 LAKE ORAL; TABLET, COATED
DYE FDC BLUE #2 LAKE ORAL; TABLET, CONTROLLED RELEASE
DYE FDC BLUE #2 LAKE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC BLUE #2 LAKE ORAL; TABLET, EXTENDED RELEASE
DYE FDC BLUE #2 LAKE ORAL; TABLET, FILM COATED
DYE FDC BLUE #2 LAKE ORAL; TABLET, ORALLY DISINTEGRATING
DYE FDC BLUE #2 LAKE ORAL; TABLET, REPEAT ACTION
DYE FDC BLUE #2 LAKE ORAL; TABLET, SUSTAINED ACTION
DYE FDC BLUE #2 LAKE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
DYE FDC BLUE #2 LAKE ORAL; TABLET, UNCOATED, TROCHE
DYE FDC BLUE #2 LAKE ORAL-21; TABLET
DYE FDC BLUE #2 LAKE ORAL-28; TABLET

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Last Modified: 29 April 2006
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