# Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products
> **Food and Drug Administration** · Final rule. · Published 1998-07-30 · 63 FR 40647
## Document
- **Document number:** 98-20303
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 40647
- **CFR reference:** 21 CFR 310
- **Publication date:** 1998-07-30
- **HHS docket:** Docket No. 76N-052N
## Abstract

The Food and Drug Administration (FDA) is amending the final monograph for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion caused by acute or chronic rhinitis) to add the ingredient levmetamfetamine (formerly l- desoxyephedrine) and to classify this ingredient as generally recognized as safe and effective for OTC use. The agency is also removing l-desoxyephedrine from the list of nonmonograph active ingredients. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/07/30/98-20303/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use)
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