Substances & reference · openFDA

NDC SPL data elements

Every package NDC listed in drug labeling, with its marketing category, dates and application number. 672,578 records; openFDA updated it 2026-11-13. About this dataset

Newest records

Marketing category
  • ANDA262,693
  • OTC Monograph Drug100,764
  • OTC monograph not final83,531
  • unapproved homeopathic52,802
  • NDA45,540
  • OTC monograph final27,921
  • unapproved drug other25,815
  • BLA25,038
  • Alprazolam

    TABLET · HUMAN PRESCRIPTION DRUG · ANDA213204

    29300-361-10ANDA
  • Dove

    STICK · HUMAN OTC DRUG · M019

    64942-2577-1OTC Monograph Drug
  • Xospata

    TABLET · HUMAN PRESCRIPTION DRUG · NDA211349

    0469-1425-70NDA
  • Alprazolam

    TABLET · HUMAN PRESCRIPTION DRUG · ANDA213204

    29300-360-05ANDA
  • Sefudun Quit Smoking Nicotine Patches (7Mg)

    PATCH · HUMAN OTC DRUG · 505G(a)(3)

    83804-019-01OTC Monograph Drug
  • Nitrogen

    GAS · HUMAN PRESCRIPTION DRUG · NDA205850

    88048-002-07NDA
  • Bubble And Co Daily Defense Sunscreen

    CREAM · HUMAN OTC DRUG · M020

    88119-111-01OTC Monograph Drug
  • Alprazolam

    TABLET · HUMAN PRESCRIPTION DRUG · ANDA213204

    29300-363-10ANDA
  • Lacosamide

    SOLUTION · HUMAN PRESCRIPTION DRUG · ANDA216151

    0121-2024-94ANDA
  • Pirfenidone

    TABLET, FILM COATED · HUMAN PRESCRIPTION DRUG · ANDA212674

    82249-115-27ANDA
  • Lacosamide

    SOLUTION · HUMAN PRESCRIPTION DRUG · ANDA216151

    0121-1012-94ANDA
  • Alprazolam

    TABLET · HUMAN PRESCRIPTION DRUG · ANDA213204

    29300-362-10ANDA
  • Huddle Barrier Balm

    OINTMENT · HUMAN OTC DRUG · M016

    87366-001-34OTC Monograph Drug
  • Arnica Bruise

    CREAM · HUMAN OTC DRUG

    88028-003-01unapproved homeopathic
  • Sugammadex

    INJECTION · HUMAN PRESCRIPTION DRUG · ANDA215701

    83301-0077-1ANDA
  • Lisinopril And Hydrochlorothiazide

    TABLET · HUMAN PRESCRIPTION DRUG · ANDA077912

    67046-0686-3ANDA
  • Dermeleve

    CREAM · HUMAN OTC DRUG · M016

    81507-002-07OTC Monograph Drug
  • Pain Relief Gel-Patch

    PATCH · HUMAN OTC DRUG · 505G(a)(3)

    73581-915-30OTC Monograph Drug
  • Zkbb Eczema

    CREAM · HUMAN OTC DRUG · M016

    87083-024-01OTC Monograph Drug
  • Nitrogen

    GAS · HUMAN PRESCRIPTION DRUG · NDA205850

    88048-002-02NDA
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.