DailyMed labels

The audit

Who controls it

Drug companies submit labeling. NLM hosts the submitted in-use text and says it does not review the labeling before publication; the text may differ from the latest FDA-approved label, and FDA approval varies by product type.

Money

DailyMed's specific operating budget was not identified. FDA's FY2025 Prescription Drug User Fee Act (PDUFA) human-drug-review program had $1.759 billion in obligations, including $1.360 billion (77%) from user fees and $399.0 million (23%) from appropriations; those figures are not DailyMed or whole-FDA funding.

Conflict rules

The sampled label names its manufacturer or packager but shows no author-level financial conflict disclosure. The reviewed DailyMed material did not establish a product-specific disclosure system; FDA review applies to covered products.

Method

A label provides regulated product-use information, not an independent evidence review or graded review of studies. FDA's Pregnancy and Lactation Labeling Rule, effective June 30, 2015, replaced pregnancy letter categories with narrative risk summaries for covered prescription labels; the rule does not cover over-the-counter products.

Dates on its pages

Each label has its own date and DailyMed provides an archive; the sampled Tylenol Extra Strength label says it was updated June 15, 2026.

Political exposure

FDA leadership changed from Commissioner Marty Makary (March 25, 2025 to May 13, 2026) to Acting Commissioner Kyle Diamantas from May 15, 2026. FDA's September 22, 2025 acetaminophen announcement began a label-change process, but the sampled 2026 over-the-counter label retained its ordinary pregnancy wording and the audit found no politically ordered change to it.

Money exposure

Companies have product and labeling interests, and pooled PDUFA fees fund allowable human-drug-review costs under statutory conditions. FDA says fees are not paid for a particular decision; the audit found no evidence that a payer obtained a favorable label decision or that a company changed the sampled Tylenol wording in response to the 2025 announcement.

Track record

In the valproate backtest, the Depakote label was revised in March 2026 and included indication-specific pregnancy warnings; some warning language appeared in archived labels by 2015, but the exact lag from the 2013 FDA communication is unknown. The codeine label says breastfeeding is not recommended during treatment, not that breastfeeding is a formal label contraindication. A separate Tylenol Regular Strength label in the acetaminophen backtest was updated May 27, 2026 and had no neurodevelopment warning.

Where this comes from

• DailyMed about page
• Sample Tylenol Extra Strength label
• FDA pregnancy and lactation labeling resources
• FDA FY2025 PDUFA financial report
• FDA acetaminophen announcement