According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products are in this database.
FDA Inactive Ingredients
Description
The Inactive Ingredients files are supplied as comma delimited text and Excel files. The size of each unzipped file is less than 2 MB.
More info: Center for Drug Evaluation and Research Inactive Ingredients Search FAQ
Source links
Download
Download page: Center for Drug Evaluation and Research Inactive Ingredients Database Download
Download URL format: https://www.fda.gov/media/180439/download?attachment
NOTE: the 180439 likely changes over time because the archived updates have different numbers here…
Example download file: Inactive Ingredients Database Download File
API
Search
Search Inactive Ingredients
Licensing
Update frequency
Quarterly, by the tenth working day of April, July, October, and January.
Table info
The data file contains 7 fields (columns):
- Inactive Ingredient
- Route
- Dosage Form
- CAS Number
- UNII
- Potency Amount
- Potency Unit
On this page
- FDA Inactive Ingredients
- Description
- Source links
- Download
- API
- Search
- Licensing
- Update frequency
- Table info