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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
BUTYL ALCOHOL ORAL; CAPSULE
BUTYL ALCOHOL ORAL; TABLET, COATED
BUTYL ALCOHOL TOPICAL; SOLUTION
BUTYL ALCOHOL TOPICAL; SWAB
BUTYL ALCOHOL, TERTIARY TOPICAL; GEL
BUTYL ESTER OF PVM/MA COPOLYMER TOPICAL; SOLUTION
BUTYL STEARATE TOPICAL; EMULSION, CREAM
BUTYL STEARATE TOPICAL; LOTION
BUTYLATED HYDROXYANISOLE INTRAMUSCULAR; INJECTION
BUTYLATED HYDROXYANISOLE IV(INFUSION); INJECTION
BUTYLATED HYDROXYANISOLE IV(INFUSION); POWDER, FOR INJECTION SOLUTION
BUTYLATED HYDROXYANISOLE NASAL; SOLUTION
BUTYLATED HYDROXYANISOLE NASAL; SPRAY, METERED
BUTYLATED HYDROXYANISOLE ORAL; CAPSULE
BUTYLATED HYDROXYANISOLE ORAL; CAPSULE, SOFT GELATIN
BUTYLATED HYDROXYANISOLE ORAL; CONCENTRATE
BUTYLATED HYDROXYANISOLE ORAL; EMULSION
BUTYLATED HYDROXYANISOLE ORAL; GRANULE, FOR SUSPENSION
BUTYLATED HYDROXYANISOLE ORAL; SOLUTION
BUTYLATED HYDROXYANISOLE ORAL; SUSPENSION
BUTYLATED HYDROXYANISOLE ORAL; TABLET
BUTYLATED HYDROXYANISOLE ORAL; TABLET, FILM COATED
BUTYLATED HYDROXYANISOLE RECTAL; SUPPOSITORY
BUTYLATED HYDROXYANISOLE SUBLINGUAL; TABLET
BUTYLATED HYDROXYANISOLE TOPICAL; EMULSION, CREAM
BUTYLATED HYDROXYANISOLE TOPICAL; GEL
BUTYLATED HYDROXYANISOLE TOPICAL; LOTION
BUTYLATED HYDROXYANISOLE TOPICAL; OINTMENT
BUTYLATED HYDROXYANISOLE TOPICAL; SOLUTION
BUTYLATED HYDROXYANISOLE VAGINAL; EMULSION, CREAM
BUTYLATED HYDROXYANISOLE VAGINAL; OINTMENT
BUTYLATED HYDROXYANISOLE VAGINAL; SUPPOSITORY
BUTYLATED HYDROXYTOLUENE BUCCAL; GUM, CHEWING
BUTYLATED HYDROXYTOLUENE INTRAMUSCULAR; INJECTION
BUTYLATED HYDROXYTOLUENE INTRAVENOUS; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
BUTYLATED HYDROXYTOLUENE IV(INFUSION); INJECTION
BUTYLATED HYDROXYTOLUENE IV(INFUSION); POWDER, FOR INJECTION SOLUTION
BUTYLATED HYDROXYTOLUENE NASAL; SPRAY, METERED
BUTYLATED HYDROXYTOLUENE ORAL; CAPSULE
BUTYLATED HYDROXYTOLUENE ORAL; CAPSULE, SOFT GELATIN
BUTYLATED HYDROXYTOLUENE ORAL; SOLUTION
BUTYLATED HYDROXYTOLUENE ORAL; SOLUTION, LIQUID, CONCENTRATE, ORAL
BUTYLATED HYDROXYTOLUENE ORAL; TABLET
BUTYLATED HYDROXYTOLUENE ORAL; TABLET (IMMED./COMP. RELEASE), FILM COATED
BUTYLATED HYDROXYTOLUENE ORAL; TABLET, CONTROLLED RELEASE
BUTYLATED HYDROXYTOLUENE ORAL; TABLET, EXTENDED RELEASE
BUTYLATED HYDROXYTOLUENE ORAL; TABLET, FILM COATED
BUTYLATED HYDROXYTOLUENE ORAL; TABLET, SUSTAINED ACTION
BUTYLATED HYDROXYTOLUENE RECTAL; SUPPOSITORY
BUTYLATED HYDROXYTOLUENE TOPICAL; CREAM, AUGMENTED
BUTYLATED HYDROXYTOLUENE TOPICAL; CREAM, EMULSION, SUSTAINED RELEASE
BUTYLATED HYDROXYTOLUENE TOPICAL; EMULSION, AEROSOL FOAM
BUTYLATED HYDROXYTOLUENE TOPICAL; EMULSION, CREAM
BUTYLATED HYDROXYTOLUENE TOPICAL; GEL
BUTYLATED HYDROXYTOLUENE TOPICAL; OINTMENT
BUTYLATED HYDROXYTOLUENE TOPICAL; SHAMPOO
BUTYLATED HYDROXYTOLUENE TOPICAL; SOLUTION
BUTYLATED HYDROXYTOLUENE TOPICAL; SWAB
BUTYLATED HYDROXYTOLUENE VAGINAL; EMULSION, CREAM
BUTYLATED HYDROXYTOLUENE VAGINAL; SUPPOSITORY
BUTYLENE GLYCOL TRANSDERMAL; FILM, CONTROLLED RELEASE
BUTYLENE GLYCOL TRANSDERMAL; PATCH, CONTROLLED RELEASE
BUTYLPARABEN INTRAMUSCULAR; INJECTION
BUTYLPARABEN ORAL; CAPSULE
BUTYLPARABEN ORAL; CAPSULE, SUSTAINED ACTION
BUTYLPARABEN ORAL; DROPS
BUTYLPARABEN ORAL; SOLUTION
BUTYLPARABEN ORAL; SUSPENSION
BUTYLPARABEN ORAL; SYRUP
BUTYLPARABEN ORAL; TABLET
BUTYLPARABEN ORAL; TABLET, COATED
BUTYLPARABEN ORAL; TABLET, REPEAT ACTION
BUTYLPARABEN ORAL; TABLET, SUSTAINED ACTION
BUTYLPARABEN ORAL; TABLET, SUSTAINED ACTION, COATED
BUTYLPARABEN RECTAL; SOLUTION
BUTYLPARABEN TOPICAL; EMULSION, CREAM
BUTYLPARABEN TOPICAL; LOTION
BUTYLPARABEN TOPICAL; OINTMENT
C20-40 PARETH-24 TOPICAL; SOLUTION
CAFFEINE NASAL; SPRAY, METERED
CAFFEINE OPHTHALMIC; SOLUTION
CALCIUM INTRAMUSCULAR; INJECTION
CALCIUM ACETATE ORAL; SUSPENSION
CALCIUM ACETATE ORAL-20; TABLET
CALCIUM ACETATE ORAL-21; TABLET
CALCIUM ACETATE ORAL-28; TABLET
CALCIUM ACETATE TOPICAL; EMULSION, CREAM
CALCIUM ACETATE TOPICAL; LOTION
CALCIUM ALGINATE AND AMMONIUM ALGINATE ORAL; TABLET
CALCIUM ASCORBATE ORAL; SUSPENSION
CALCIUM CARBONATE AURICULAR (OTIC); SOLUTION
CALCIUM CARBONATE BUCCAL; GUM, CHEWING
CALCIUM CARBONATE ORAL; CAPSULE
CALCIUM CARBONATE ORAL; CAPSULE, HARD GELATIN
CALCIUM CARBONATE ORAL; CAPSULE, SUSTAINED ACTION
CALCIUM CARBONATE ORAL; TABLET
CALCIUM CARBONATE ORAL; TABLET (IMMED./COMP. RELEASE), FILM COATED
CALCIUM CARBONATE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
CALCIUM CARBONATE ORAL; TABLET, COATED
CALCIUM CARBONATE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED

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Last Modified: 29 April 2006
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