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 DC BLUE #2 LAKE	ORAL; TABLET
DYE DC BLUE #2 LAKE	ORAL; TABLET, COATED
DYE DC BLUE #6	ORAL; CAPSULE
DYE DC GREEN #1 LAKE	ORAL; TABLET
DYE DC GREEN #3 LAKE	ORAL; CAPSULE
DYE DC GREEN #3 LAKE	ORAL; TABLET, COATED
DYE DC GREEN #4	ORAL; CAPSULE
DYE DC GREEN #5	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC GREEN #5	ORAL; SOLUTION
DYE DC GREEN #5	ORAL; SOLUTION, ELIXIR
DYE DC GREEN #5	ORAL; TABLET
DYE DC GREEN #5	ORAL; TABLET, COATED
DYE DC GREEN #5	ORAL-21; TABLET
DYE DC GREEN #5	ORAL-28; TABLET
DYE DC GREEN #5	TOPICAL; EMULSION, CREAM
DYE DC GREEN #5	TOPICAL; LOTION
DYE DC ORANGE #3	ORAL; SOLUTION, ELIXIR
DYE DC RED #19	ORAL; SUSPENSION
DYE DC RED #19	ORAL; TABLET
DYE DC RED #19	TOPICAL; EMULSION
DYE DC RED #2 LAKE	ORAL; CAPSULE
DYE DC RED #2 LAKE	ORAL; TABLET
DYE DC RED #2 LAKE	ORAL; TABLET, COATED
DYE DC RED #21 LAKE	ORAL; CAPSULE
DYE DC RED #21 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC RED #22	ORAL; CAPSULE
DYE DC RED #22	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #22	ORAL; TABLET, COATED
DYE DC RED #27	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #27	ORAL; TABLET
DYE DC RED #27	ORAL; TABLET, COATED
DYE DC RED #27 LAKE	ORAL; CAPSULE
DYE DC RED #27 LAKE	ORAL; TABLET
DYE DC RED #27 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC RED #27 LAKE	ORAL; TABLET, FILM COATED
DYE DC RED #27 LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE DC RED #27 LAKE	ORAL; TABLET, SUSTAINED ACTION, COATED
DYE DC RED #27 LAKE	ORAL-28; TABLET
DYE DC RED #28	ORAL; CAPSULE
DYE DC RED #28	ORAL; CAPSULE, COATED, SOFT GELATIN
DYE DC RED #28	ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC RED #28	ORAL; CAPSULE, EXTENDED RELEASE
DYE DC RED #28	ORAL; CAPSULE, HARD GELATIN
DYE DC RED #28	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #28	ORAL; POWDER, FOR SUSPENSION
DYE DC RED #28	ORAL; SUSPENSION
DYE DC RED #28	ORAL; TABLET
DYE DC RED #28	TOPICAL; AEROSOL
DYE DC RED #28 LAKE	ORAL; CAPSULE
DYE DC RED #28 LAKE	ORAL-28; TABLET
DYE DC RED #3 LAKE	ORAL; CAPSULE
DYE DC RED #3 LAKE	ORAL; TABLET
DYE DC RED #3 LAKE	ORAL; TABLET, FILM COATED
DYE DC RED #3 LAKE	SUBLINGUAL; TABLET
DYE DC RED #30	ORAL; CAPSULE
DYE DC RED #30	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #30	ORAL; TABLET
DYE DC RED #30	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC RED #30	ORAL; TABLET, COATED
DYE DC RED #30	ORAL; TABLET, DELAYED ACTION
DYE DC RED #30	ORAL; TABLET, FILM COATED
DYE DC RED #30	ORAL-21; TABLET
DYE DC RED #30	ORAL-28; TABLET
DYE DC RED #30 LAKE	ORAL; CAPSULE
DYE DC RED #30 LAKE	ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE DC RED #30 LAKE	ORAL; GRANULE, FOR SUSPENSION
DYE DC RED #30 LAKE	ORAL; POWDER
DYE DC RED #30 LAKE	ORAL; TABLET
DYE DC RED #30 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE DC RED #30 LAKE	ORAL; TABLET, COATED
DYE DC RED #30 LAKE	ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE DC RED #30 LAKE	ORAL; TABLET, ENTERIC COATED PARTICLES
DYE DC RED #30 LAKE	ORAL; TABLET, FILM COATED
DYE DC RED #30 LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE DC RED #30 LAKE	ORAL-21; TABLET
DYE DC RED #33	DENTAL; SOLUTION
DYE DC RED #33	ORAL; CAPSULE
DYE DC RED #33	ORAL; CAPSULE, HARD GELATIN
DYE DC RED #33	ORAL; CAPSULE, SOFT GELATIN
DYE DC RED #33	ORAL; CAPSULE, SOFT GELATIN LIQUID-FILLED
DYE DC RED #33	ORAL; CAPSULE, SUSTAINED ACTION
DYE DC RED #33	ORAL; CONCENTRATE
DYE DC RED #33	ORAL; SOLUTION
DYE DC RED #33	ORAL; SOLUTION, ELIXIR
DYE DC RED #33	ORAL; SUSPENSION
DYE DC RED #33	ORAL; SUSPENSION, LIQUID
DYE DC RED #33	ORAL; SUSPENSION, SUSTAINED ACTION
DYE DC RED #33	ORAL; SYRUP
DYE DC RED #33	ORAL; TABLET
DYE DC RED #33	ORAL; TABLET, COATED
DYE DC RED #33	ORAL; TABLET, FILM COATED
DYE DC RED #33	TOPICAL; SHAMPOO
DYE DC RED #33 LAKE	ORAL; CAPSULE
DYE DC RED #33 LAKE	ORAL; SYRUP
DYE DC RED #33 LAKE	ORAL; TABLET
DYE DC RED #36	ORAL; TABLET
DYE DC RED #36	TOPICAL; EMULSION, CREAM
DYE DC RED #36	TOPICAL; OINTMENT
DYE DC RED #39	TOPICAL; LOTION
DYE DC RED #4 LAKE	ORAL; CAPSULE

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