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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
DIMETHYLDIOCTADECYLAMMONIUM BENTONITE RECTAL; SUSPENSION
DIMETHYLSILOXANE/METHYLVINYLSILOXANE COPOLYMER IMPLANTATION; PELLET, IMPLANT
DIMETHYLSILOXANE/METHYLVINYLSILOXANE COPOLYMER IMPLANTATION; ROD
DIMYRISTOYL LECITHIN INTRAVENOUS; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
DIMYRISTOYL LECITHIN IV(INFUSION); SUSPENSION, INJECTION
DIMYRISTOYL PHOSPHATIDYLGLYCEROL IV(INFUSION); SUSPENSION, INJECTION
DIOCTYLPHTHALATE OPHTHALMIC; SUPPOSITORY, INSERT, CONTROLLED RELEASE
DIOCTYLPHTHALATE TRANSDERMAL; FILM, CONTROLLED RELEASE
DIOLEOYL LECITHIN EPIDURAL; INJECTION, SUSPENSION, LIPOSOMAL
DIPALMITOYL PHOSPHATIDYLGLYCEROL EPIDURAL; INJECTION, SUSPENSION, LIPOSOMAL
DIPROPYLENE GLYCOL BUCCAL; PATCH, CONTROLLED RELEASE
DIPROPYLENE GLYCOL TRANSDERMAL; FILM, CONTROLLED RELEASE
DIPROPYLENE GLYCOL TRANSDERMAL; PATCH, CONTROLLED RELEASE
DISODIUM COCOAMPHODIACETATE TOPICAL; SHAMPOO, SUSPENSION
DISODIUM EDISYLATE ORAL; SOLUTION
DISODIUM EDISYLATE ORAL; TABLET
DISODIUM LAURETH SULFOSUCCINATE TOPICAL; GEL
DISODIUM LAURETH SULFOSUCCINATE TOPICAL; SHAMPOO
DISODIUM LAURYL SULFOSUCCINATE TOPICAL; SHAMPOO
DISODIUM SULFOSALICYLATE IV(INFUSION); POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
DISOFENIN IV(INFUSION); INJECTION
DISTEAROYL LECITHIN INTRAVENOUS; SOLUTION, LIPOSOME, INJECTION
DISTEAROYL PHOSPHATIDYLGLYCEROL INTRAVENOUS; INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
DIVINYLBENZENE STYRENE COPOLYMER OPHTHALMIC; SUSPENSION, DROPS
DOCOSANOL TOPICAL; SOLUTION
DOCUSATE SODIUM INTRAMUSCULAR; INJECTION
DOCUSATE SODIUM ORAL; CAPSULE
DOCUSATE SODIUM ORAL; CAPSULE, HARD GELATIN
DOCUSATE SODIUM ORAL; CAPSULE, SUSTAINED ACTION
DOCUSATE SODIUM ORAL; GRANULE, FOR SUSPENSION, EXTENDED RELEASE
DOCUSATE SODIUM ORAL; SUSPENSION
DOCUSATE SODIUM ORAL; SUSPENSION, SUSTAINED ACTION
DOCUSATE SODIUM ORAL; TABLET
DOCUSATE SODIUM ORAL; TABLET (IMMED./COMP. RELEASE), FILM COATED
DOCUSATE SODIUM ORAL; TABLET, COATED
DOCUSATE SODIUM ORAL; TABLET, FILM COATED
DOCUSATE SODIUM ORAL; TABLET, SUSTAINED ACTION, FILM COATED
DOCUSATE SODIUM TOPICAL; GEL
DOCUSATE SODIUM TOPICAL; SHAMPOO
DOCUSATE SODIUM/SODIUM BENZOATE ORAL; CAPSULE
DOCUSATE SODIUM/SODIUM BENZOATE ORAL; TABLET
DOCUSATE SODIUM/SODIUM BENZOATE ORAL; TABLET, FILM COATED
DRI KLEAR ORAL; TABLET
DRI KLEAR 042 ORAL; TABLET
DRI KLEAR 042 ORAL; TABLET, COATED
DRI KLEAR 042 ORAL; TABLET, FILM COATED
DRY FLO ORAL; TABLET
DRY-CLEAR LV ORAL; TABLET
DURO-TAK 280-2516 TRANSDERMAL; FILM, CONTROLLED RELEASE
DURO-TAK 80-1196 TRANSDERMAL; FILM, CONTROLLED RELEASE
DURO-TAK 87-2070 TRANSDERMAL; FILM, CONTROLLED RELEASE
DURO-TAK 87-2194 TRANSDERMAL; FILM, CONTROLLED RELEASE
DURO-TAK 87-2287 TRANSDERMAL; FILM, CONTROLLED RELEASE
DURO-TAK 87-2296 TRANSDERMAL; PATCH, CONTROLLED RELEASE
DURO-TAK 87-2888 TRANSDERMAL; PATCH
DURO-TAK 87-2979 TRANSDERMAL; FILM, CONTROLLED RELEASE
DUSTING POWDER ORAL; TABLET
DUSTING POWDER ORAL; TABLET, COATED
DYE BEIGE P-1437 ORAL; TABLET
DYE BLACK LB-1171 ORAL; TABLET
DYE BLACK LB-442 ORAL; TABLET
DYE BLACK LB-636 ORAL-28; TABLET
DYE BLACK LB-9972 ORAL; TABLET
DYE BLACK OXIDE ORAL; CAPSULE
DYE BLUE #1 ORAL; CAPSULE
DYE BLUE #1 ORAL; CAPSULE, SUSTAINED ACTION
DYE BLUE #1 ORAL; SOLUTION
DYE BLUE #1 ORAL; TABLET
DYE BLUE #1 ORAL; TABLET, SUSTAINED ACTION
DYE BLUE #1 LAKE ORAL; TABLET
DYE BLUE #2 ORAL; TABLET
DYE BLUE #2 ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE BLUE LAKE BLEND LB-332 ORAL; TABLET
DYE BLUE LAKOLENE ORAL; TABLET
DYE BLUE LB-781 ORAL; TABLET
DYE BROWN LAKE ORAL; TABLET
DYE BROWN LAKE BLEND ORAL; TABLET
DYE BROWN LAKE BLEND LB-1685 ORAL; TABLET
DYE BROWN LB-292 ORAL; TABLET
DYE BROWN LB-464 ORAL; TABLET
DYE BURNT UMBER ORAL; TABLET, FILM COATED
DYE CARAMEL 105 ORAL; SYRUP
DYE CARAMEL ACID PROOF 100 ORAL; SOLUTION, ELIXIR
DYE CARAMEL ACID PROOF 100 ORAL; SYRUP
DYE CARMINE 09349 ORAL; TABLET, FILM COATED
DYE CASING 27-75 ORAL; POWDER, FOR SUSPENSION
DYE CHROMA-TERIC DEB-5037-ORE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE CHROMA-TERIC T3000-WE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE CHROMA-TERIC YELLOW T3277-YE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
DYE CHROMA-TONE ORAL; CAPSULE
DYE CHROMA-TONE ORAL; TABLET, FILM COATED
DYE CHROMA-TONE PDDB-8906W ORAL; TABLET
DYE CHROMA-TONE-P DDB-8746-OR ORAL; TABLET
DYE DC BLACK #1 ORAL; TABLET
DYE DC BLUE #1 ORAL; CAPSULE
DYE DC BLUE #1 ORAL; POWDER, FOR SUSPENSION
DYE DC BLUE #1 ORAL; TABLET
DYE DC BLUE #1 ORAL; TABLET, FILM COATED
DYE DC BLUE #1 LAKE ORAL; TABLET
DYE DC BLUE #2 LAKE ORAL; CAPSULE

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Last Modified: 29 April 2006
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