非处方药 - 相关文章

21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]

21CFR 2026-07-27

21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:64 FR 2768

21 CFR Part 355 - Anticaries Drug Products for Over-the-Counter Human Use

21CFR 2026-07-27

21 CFR Part 355 - Anticaries Drug Products for Over-the-Counter Human UsePART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:60 FR 52507, Oct. 6, 1995, unless otherwise noted.Ed

21 CFR Part 358 Subpart B -- Wart Remover Drug Products

21CFR 2026-07-27

21 CFR Part 358 Subpart B -- Wart Remover Drug ProductsSubpart B—Wart Remover Drug Products§ 358.101 Scope.(a) An over-the-counter wart remover drug product in a form suitable for topical application is generally recognized as safe and effective and

21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human Use

21CFR 2026-07-27

21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human UsePART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:55 FR 33255, Aug. 14, 1990,

21 CFR Part 358 Subpart D—Ingrown Toenail Relief Drug Products

21CFR 2026-07-27

21 CFR Part 358 Subpart D—Ingrown Toenail Relief Drug ProductsSubpart D—Ingrown Toenail Relief Drug ProductsSource:68 FR 24348, May 7, 2003, unless otherwise noted.§ 358.301 Scope.(a) An over-the-counter ingrown toenail relief drug product in a form

21 CFR Part 358 Subpart F—Corn and Callus Remover Drug Products

21CFR 2026-07-27

(a) An over-the-counter corn and callus remover drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in § 330.1 of this chapter.

美国OTC专论NDC查询系统：一站式FDA非处方药信息查询工具

NDC申报 2026-07-15

美国OTC专论NDC查询系统：在线免费查询FDA OTC专论药物NDC编码，支持包装NDC、产品NDC、制造商、专论编号、活性成分5种方式，助您轻松完成药品合规与跨境电商审核。

指甲真菌液出口美国OTC注册指南：M005抗真菌专论与NDC登记全流程

OTC申报 2026-07-14

2026年多家中国企业指甲真菌液产品通过FDA NDC注册进入美国市场。OTC专论M005允许7类活性成分用于抗真菌OTC药品，但适应症仅限足癣、股癣和体癣，未明确收录甲癣。企业须精准设计标签宣称，区分抑制真菌生长与治疗甲癣的合规边界，并完成FDA企业注册与NDC产品列名。

去疣剂出口美国合规指南：OTC专论M028与NDC注册全流程解析

OTC申报 2026-07-14

2026年多款去疣剂产品通过FDA的NDC注册成功进入美国市场，OTC专论M028是去疣剂合规的核心依据。去疣剂唯一允许的活性成分为水杨酸，浓度因剂型不同分为5%至40%三档。出口企业须完成FDA企业注册、NDC产品列名、Drug Facts标签合规及cGMP验证，方可合法销售。本文详解全流程实操要点。

防晒产品出口美国OTC注册全流程：从专论合规到NDC登记实操指南

出口指南 2026-07-14

2026年8月FDA防晒专论M020新规即将生效，Bemotrizinol成为近20年首个新增防晒活性成分。防晒产品在美国按OTC药品管理，出口企业须完成FDA企业注册、NDC产品列名、Drug Facts标签合规及cGMP符合性验证。本文详解防晒产品从专论判定到NDC登记的全流程实操要点。