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.

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Inactive Ingredient	Route / Dosage Form
DYE FDC BLUE #40 HT LAKE	ORAL; TABLET
DYE FDC BROWN R LB-56069	BUCCAL; GUM, CHEWING
DYE FDC BROWN R LB-56069	ORAL; TABLET
DYE FDC GREEN #1	ORAL; TABLET
DYE FDC GREEN #1 LAKE	ORAL; TABLET
DYE FDC GREEN #1 LAKE	SUBLINGUAL; TABLET
DYE FDC GREEN #3	DENTAL; GEL
DYE FDC GREEN #3	ORAL; CAPSULE
DYE FDC GREEN #3	ORAL; CAPSULE, COATED, SOFT GELATIN
DYE FDC GREEN #3	ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC GREEN #3	ORAL; CAPSULE, EXTENDED RELEASE
DYE FDC GREEN #3	ORAL; CAPSULE, SOFT GELATIN
DYE FDC GREEN #3	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC GREEN #3	ORAL; SOLUTION, ELIXIR
DYE FDC GREEN #3	ORAL; SYRUP
DYE FDC GREEN #3	ORAL; TABLET
DYE FDC GREEN #3	ORAL; TABLET, COATED
DYE FDC GREEN #3	ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC GREEN #3	RECTAL; SUPPOSITORY
DYE FDC GREEN LB-1174	ORAL-28; TABLET
DYE FDC GREEN LB-3323	ORAL; TABLET
DYE FDC GREEN LB-9583	ORAL; TABLET
DYE FDC LB483	ORAL; TABLET
DYE FDC ORANGE #2	ORAL; TABLET, COATED
DYE FDC ORANGE LB-452	ORAL; TABLET
DYE FDC PURPLE LB588	ORAL; TABLET
DYE FDC PURPLE LB-694	ORAL; TABLET
DYE FDC RED #1	ORAL; CAPSULE
DYE FDC RED #1	ORAL; TABLET
DYE FDC RED #1	ORAL; TABLET, COATED
DYE FDC RED #19	ORAL; TABLET
DYE FDC RED #2	ORAL; CAPSULE
DYE FDC RED #2	ORAL; CAPSULE, SOFT GELATIN
DYE FDC RED #2	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #2	ORAL; CONCENTRATE
DYE FDC RED #2	ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #2	ORAL; SOLUTION, ELIXIR
DYE FDC RED #2	ORAL; SUSPENSION
DYE FDC RED #2	ORAL; SYRUP
DYE FDC RED #2	ORAL; TABLET
DYE FDC RED #2	ORAL; TABLET, COATED
DYE FDC RED #2	ORAL; TABLET, FILM COATED
DYE FDC RED #2	ORAL-20; TABLET
DYE FDC RED #2 LAKE	ORAL; TABLET
DYE FDC RED #27 LAKE	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #27 LAKE	ORAL; TABLET
DYE FDC RED #28	ORAL; CAPSULE
DYE FDC RED #28	ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #3	ORAL; CAPSULE
DYE FDC RED #3	ORAL; CAPSULE, HARD GELATIN
DYE FDC RED #3	ORAL; CAPSULE, SOFT GELATIN
DYE FDC RED #3	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #3	ORAL; DROPS
DYE FDC RED #3	ORAL; GRANULE
DYE FDC RED #3	ORAL; POWDER, FOR ORAL SUSPENSION
DYE FDC RED #3	ORAL; POWDER, FOR SOLUTION
DYE FDC RED #3	ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #3	ORAL; SOLUTION, ELIXIR
DYE FDC RED #3	ORAL; SUSPENSION
DYE FDC RED #3	ORAL; SYRUP
DYE FDC RED #3	ORAL; TABLET
DYE FDC RED #3	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC RED #3	ORAL; TABLET, COATED
DYE FDC RED #3	ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC RED #3	ORAL; TABLET, EXTENDED RELEASE
DYE FDC RED #3	ORAL; TABLET, FILM COATED
DYE FDC RED #3	ORAL; TABLET, SUSTAINED ACTION
DYE FDC RED #3	ORAL; TABLET, SUSTAINED ACTION, COATED
DYE FDC RED #3	ORAL-20; TABLET
DYE FDC RED #3	ORAL-21; TABLET
DYE FDC RED #3	ORAL-28; TABLET
DYE FDC RED #3 LAKE	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #3 LAKE	ORAL; GRANULE
DYE FDC RED #3 LAKE	ORAL; POWDER, FOR SUSPENSION
DYE FDC RED #3 LAKE	ORAL; TABLET
DYE FDC RED #3 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC RED #3 LAKE	ORAL; TABLET, COATED
DYE FDC RED #3 LAKE	ORAL; TABLET, FILM COATED
DYE FDC RED #3 LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE FDC RED #3 LAKE	SUBLINGUAL; TABLET
DYE FDC RED #3 LAKE	TOPICAL; SOLUTION
DYE FDC RED #30 LAKE	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC RED #30 LAKE	ORAL; TABLET
DYE FDC RED #30 LAKE	ORAL; TABLET, EXTENDED RELEASE
DYE FDC RED #30 LAKE	ORAL-21; TABLET
DYE FDC RED #33	ORAL; CAPSULE
DYE FDC RED #33	ORAL; SOLUTION
DYE FDC RED #33	ORAL; SOLUTION, ELIXIR
DYE FDC RED #33	ORAL; SYRUP
DYE FDC RED #4	ORAL; CAPSULE
DYE FDC RED #4	ORAL; SOLUTION, ELIXIR
DYE FDC RED #4	ORAL; TABLET
DYE FDC RED #4	ORAL; TABLET, COATED
DYE FDC RED #4	TOPICAL; LOTION
DYE FDC RED #4	TOPICAL; SOLUTION
DYE FDC RED #40	BUCCAL; TABLET
DYE FDC RED #40	DENTAL; SOLUTION
DYE FDC RED #40	ORAL; BAR, CHEWABLE
DYE FDC RED #40	ORAL; CAPSULE
DYE FDC RED #40	ORAL; CAPSULE, COATED, SOFT GELATIN

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