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 YELLOW #5 LAKE	ORAL; CAPSULE
DYE FDC YELLOW #5 LAKE	ORAL; TABLET
DYE FDC YELLOW #5 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC YELLOW #5 LAKE	ORAL; TABLET, COATED
DYE FDC YELLOW #5 LAKE	ORAL; TABLET, FILM COATED
DYE FDC YELLOW #5 LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #5 LAKE	SUBLINGUAL; TABLET
DYE FDC YELLOW #6	INHALATION; SOLUTION
DYE FDC YELLOW #6	ORAL; CAPSULE
DYE FDC YELLOW #6	ORAL; CAPSULE, COATED PELLETS
DYE FDC YELLOW #6	ORAL; CAPSULE, HARD GELATIN
DYE FDC YELLOW #6	ORAL; CAPSULE, SOFT GELATIN
DYE FDC YELLOW #6	ORAL; CAPSULE, SOFT GELATIN LIQUID-FILLED
DYE FDC YELLOW #6	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC YELLOW #6	ORAL; CONCENTRATE
DYE FDC YELLOW #6	ORAL; DROPS
DYE FDC YELLOW #6	ORAL; LIQUID
DYE FDC YELLOW #6	ORAL; POWDER
DYE FDC YELLOW #6	ORAL; POWDER, FOR SOLUTION
DYE FDC YELLOW #6	ORAL; POWDER, FOR SUSPENSION
DYE FDC YELLOW #6	ORAL; SOLUTION
DYE FDC YELLOW #6	ORAL; SOLUTION, ELIXIR
DYE FDC YELLOW #6	ORAL; SUSPENSION
DYE FDC YELLOW #6	ORAL; SUSPENSION, LIQUID
DYE FDC YELLOW #6	ORAL; SUSPENSION, SUSTAINED ACTION
DYE FDC YELLOW #6	ORAL; SYRUP
DYE FDC YELLOW #6	ORAL; TABLET
DYE FDC YELLOW #6	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC YELLOW #6	ORAL; TABLET, COATED
DYE FDC YELLOW #6	ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC YELLOW #6	ORAL; TABLET, FILM COATED
DYE FDC YELLOW #6	ORAL; TABLET, REPEAT ACTION
DYE FDC YELLOW #6	ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #6	ORAL-21; TABLET
DYE FDC YELLOW #6	ORAL-28; TABLET
DYE FDC YELLOW #6	RECTAL; SOLUTION
DYE FDC YELLOW #6	SUBLINGUAL; TABLET
DYE FDC YELLOW #6	TOPICAL; LOTION
DYE FDC YELLOW #6	TOPICAL; SPONGE
DYE FDC YELLOW #6 HT LAKE	ORAL; CAPSULE
DYE FDC YELLOW #6 HT LAKE	ORAL; TABLET
DYE FDC YELLOW #6 HT LAKE	ORAL; TABLET, EXTENDED RELEASE
DYE FDC YELLOW #6 HT LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #6 LAKE	BUCCAL/SUBLINGUAL; TABLET
DYE FDC YELLOW #6 LAKE	ORAL; CAPSULE
DYE FDC YELLOW #6 LAKE	ORAL; CAPSULE, ENTERIC COATED PELLETS
DYE FDC YELLOW #6 LAKE	ORAL; CAPSULE, SUSTAINED ACTION
DYE FDC YELLOW #6 LAKE	ORAL; POWDER
DYE FDC YELLOW #6 LAKE	ORAL; POWDER, FOR SUSPENSION
DYE FDC YELLOW #6 LAKE	ORAL; TABLET
DYE FDC YELLOW #6 LAKE	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, COATED
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, EXTENDED RELEASE
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, FILM COATED
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, REPEAT ACTION
DYE FDC YELLOW #6 LAKE	ORAL; TABLET, SUSTAINED ACTION
DYE FDC YELLOW #6 LAKE	ORAL-21; TABLET
DYE FDC YELLOW #6 LAKE	ORAL-28; TABLET
DYE FDC YELLOW #6 LAKE	SUBLINGUAL; TABLET
DYE FERRIC OXIDE ORANGE	ORAL; TABLET
DYE GRAY #2982	ORAL; CAPSULE
DYE GREEN 70363	ORAL; TABLET
DYE GREEN AL LB-265	ORAL; TABLET
DYE GREEN ALUMINUM LB	ORAL; TABLET
DYE GREEN LAKE BLEND LB-1236	ORAL; TABLET
DYE GREEN LAKE BLEND LB-333	ORAL; TABLET
DYE GREEN LB	ORAL; TABLET
DYE GREEN LB-1594	ORAL; TABLET
DYE GREEN LB-1616	ORAL; TABLET
DYE GREEN LB-279	ORAL; TABLET
DYE GREEN LB-482	ORAL; TABLET
DYE GREEN LB-555	ORAL; TABLET
DYE GREEN LB-603	ORAL; TABLET
DYE GREEN LB-820	ORAL; TABLET
DYE GREEN LB-883	ORAL; TABLET
DYE GREEN PB-1543	ORAL; TABLET
DYE GREEN PB-1766	ORAL-28; TABLET
DYE GREEN PMS-579	ORAL; CAPSULE, SOFT GELATIN
DYE GREEN PR-1333	ORAL; TABLET
DYE GREEN PR-1339	ORAL; TABLET
DYE LAVENDER	ORAL; TABLET, FILM COATED
DYE LAVENDER LB-1356	ORAL; TABLET
DYE MINT GREEN	ORAL; TABLET
DYE MINT GREEN	ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
DYE OCHRE 3506	ORAL; TABLET
DYE OCHRE 3506	ORAL; TABLET, COATED
DYE ORANGE LB-1387	ORAL; TABLET
DYE ORANGE LB-715	ORAL; TABLET
DYE PEACH LB-1576	ORAL-21; TABLET
DYE PEACH LB-1576	ORAL-28; TABLET
DYE PINK	ORAL; CAPSULE
DYE PINK	ORAL; TABLET
DYE PINK	ORAL; TABLET, DELAYED ACTION
DYE PURPLE LAKE	ORAL; TABLET
DYE PURPLE LB-1902	ORAL; TABLET, SUSTAINED ACTION
DYE PURPLE LB-562	ORAL; TABLET
DYE PURPLE LB-639	ORAL; TABLET
DYE PURPLE LB-694	ORAL; TABLET
DYE RED #27 ALUMINUM LAKE	ORAL; TABLET

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