DailyMed

DailyMed is the U.S. National Library of Medicine’s database of FDA-approved prescription drug labeling (package inserts). It’s the authoritative source for indications, dosing, pharmacology, and contraindications — what the FDA actually approved, not editorial summary.

• DailyMed home
• Search by drug name
• Browse by drug class
• Browse by active ingredient
• Recent labeling changes

Why prefer DailyMed over Drugs.com / RxList

• Direct from the FDA’s structured product labeling (SPL) — every change is a labeling supplement reviewed by FDA.
• No advertorial content; no “patient-friendly” rewrites that drop dosing details.
• Includes the most recent labeling revisions, including boxed warnings.

Related authoritative sources

• FDA Approved Drug Products (Drugs@FDA) — approval letters, review documents, label history.
• Orange Book — Approved Drug Products w/ Therapeutic Equivalence Evaluations — generic substitutability.
• Purple Book — Biologics & Biosimilars — biologic interchangeability.
• FDA Drug Safety Communications — post-market safety alerts.
• MedWatch — adverse event reporting.

Pediatric labeling

DailyMed labels include pediatric indication, dose-by-weight or BSA, and explicit “Use in Specific Populations” sections. Many off-label peds uses are common and not reflected — cross-check with AAP Red Book and AAP statements for those.