药品企业注册与产品列名：OTC企业双义务与两年期更新
OTC药品企业须同时履行设施注册与NDC产品列名两项法定义务，且均须每两年更新。本文厘清两套义务的主体、系统入口、更新窗口与常见遗漏，帮助药品企业稳住合规节奏，避免注册失效被扣留。
去屑洗发水出口美国全套注册路径实操
去屑洗发水出口美国属OTC药品，须走M032专论符合性评估、FDA企业注册、NDC列名与标签审核全流程。本文给出可落地的注册路径与节点，帮助企业高效合规上市。
NDC产品列名12位编码规则与申报全流程
2026年FDA将NDC编号由10位统一升级为12位，OTC化妆品须同步更新产品列名（Product Listing）。本文详解12位编码结构、列名填报要点与标签展示要求，帮助企业完成合规申报。
粤妆评美国OTC化妆品FDA合规申报一站式服务全景
2026年中国功效化妆品出口美国需跨越FDA企业注册、NDC产品列名、OTC专论符合性评估与Drug Facts标签审核四道门槛。粤妆评提供从成分合规到上市申报的一站式技术服务，帮助防晒、去屑、祛痘、生发、止汗等产品合规进入美国市场。
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human Use
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human UsePART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:39 FR 19874, June 4, 1974, unless otherwise noted.Subpa
21 CFR Part 333 Subpart B - First Aid Antibiotic Drug Products
21 CFR Part 333 Subpart B - First Aid Antibiotic Drug ProductsSubpart B—First Aid Antibiotic Drug Products§ 333.101 Scope.(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized
21 CFR Part 332 - Antiflatulent Products for Over-the-Counter Human Use
21 CFR Part 332 - Antiflatulent Products for Over-the-Counter Human UsePART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:39 FR 19877, June 4, 1974, unless otherwise noted.Subpar
21 CFR Part 333 Subpart C—Topical Antifungal Drug Products
21 CFR Part 333 Subpart C—Topical Antifungal Drug ProductsSubpart C—Topical Antifungal Drug ProductsSource:58 FR 49898, Sept. 23, 1993, unless otherwise noted.§ 333.201 Scope.(a) An over-the-counter antifungal drug product in a form suitable for topi
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human Use
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human UsePART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:58 FR 54462, Oct. 21, 1993, unless otherwi
21 CFR Part 333 Subpart D—Topical Acne Drug Products
21 CFR Part 333 Subpart D—Topical Acne Drug ProductsSubpart D—Topical Acne Drug ProductsSource:56 FR 41019, Aug. 16, 1991, unless otherwise noted.§ 333.301 Scope.(a) An over-the-counter acne drug product in a form suitable for topical application is
