OBJECTIVES: The paucity of pediatric information available on drug labels hastened calls for regulatory intervention aimed at providing clinicians with improved information to treat pediatric populations, especially neonates. This study examined how neonatal drug data is presented on labels for approved drugs over the past 30 years.  METHODS: This study included review of publicly available data retrieved from the FDA website Drugs@FDA. Three sections of the FDA approved label were analyzed for mention of neonates; “Indication and Usage”, “Dosage and Administration” and “Pediatric Use”.  “Neonates” were defined as infants age 0-28 days and/or specifically cited as “neonates” or “newborns”. This analysis did not include label information pertinent to in utero exposure to drug. Descriptive statistics were performed and the pharmaceutical active ingredient was the unit of analysis. RESULTS: The study included all NDA/BLA approvals by the FDA between January 1, 1980 and December 31, 2012 and available on the Drugs@FDA website (n=676). Eleven (1.6%) labels included neonate information in the Indications and Usage section, 33 (4.9%) in the Dosage and Administration section and  62 (9.2%) in the Pediatric Use section. References to neonates occurred in two  sections on 2 labels (0.3%) and in all three sections on 5 labels (0.7%). Statements that the drug was not studied and/or not recommended in neonates were most often found in the Pediatric Use section (528, 78%), but also noted in the Dosage and Administration section (22, 3.3%) and the Indications and Usage section (9, 1.3%).  CONCLUSIONS: This study demonstrates that data necessary to determine the appropriateness of medications in neonates is difficult to find, even when available to clinicians. As regulators consider how to improve the quantity and quality of neonatal drug data, consideration should be given to standardizing neonatal information on drug labels, thereby ensuring that regulatory efforts to incentivize pediatric research are optimized.