Published July 22, 2026 | Version 1.0.0
Dataset Open

Declared Inactive Ingredients in U.S. Oral Drug Product Listings: A Census of 51,065 Eligible Distinct Product NDC Listings

Authors/Creators

Description

This dataset characterizes structured SPL inactive-ingredient declarations for a full census of 51,065 eligible distinct U.S. oral drug Product NDC listings, representing 112,295 package records, in the openFDA NDC export dated 2026-07-18.

DailyMed SPL XML was requested for 36,325 Set IDs; 22 failed requests affecting 32 product listings are retained explicitly. 51,033 products had a validated exact product/form match; 50,005 had at least one structured IACT declaration. Ingredient frequencies are conditional on that declaration-present denominator. Structured presence does not establish completeness, and results do not measure utilization or patient exposure.

The release includes product-level provenance, Product NDC-ingredient occurrences, overall and form-specific results, an ingredient-set profile sensitivity analysis, validation, methods, figures, a workbook, and code. No proprietary drug compendium or patient-level data are included.

Interactive context: HelloPharmacist NDC resource.

Notes (English)

The record-level CC BY 4.0 selection applies to original HelloPharmacist content; reproduction code is additionally available under MIT. Underlying source facts retain their legal status and source terms. Neither FDA nor NLM has reviewed or endorsed this derived dataset.

 

Files

HelloPharmacist_Declared_Inactive_Ingredients_Oral_Product_Census_Methodology_v1.0.pdf

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Additional details

Related works

Is derived from
Other: https://open.fda.gov/apis/drug/ndc/ (URL)
Other: https://dailymed.nlm.nih.gov/dailymed/app-support-web-services.cfm (URL)
Is supplemented by
Other: https://hellopharmacist.com/ndc (URL)