# Laxative Drug Products for Over-the-Counter Human Use
> **Food and Drug Administration** · Final rule. · Published 1999-01-29 · Effective 1999-01-29 · 64 FR 4535
## Document
- **Document number:** 99-1938
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 64 FR 4535
- **CFR reference:** 21 CFR 310
- **Publication date:** 1999-01-29
- **Effective date:** 1999-01-29
- **HHS docket:** Docket No. 78N-036L
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1999/01/29/99-1938/laxative-drug-products-for-over-the-counter-human-use)
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