FDA 药品与器械查询

实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。

数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。

支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。

上市药品（NDC）器械分类 510(k) 许可

查询美国市场在售药品：剂型、给药途径、活性成分、持证商与 NDC 编码，用于判断目标品种在美国是否已有同类上市。

已将中文关键词转为英文「aspirin」检索 FDA 数据库。

共找到 844 条与「aspirin」匹配的结果

当前展示 50 条美国 FDA 上市药品记录；海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›

药品名称	NDC 编码	剂型	给药途径	活性成分	持证商	上市类别
Medi-First Extra Strength Non Aspirin Acetaminophen	47682-173	TABLET	ORAL	ACETAMINOPHEN 500 mg/1	Unifirst First Aid Corporation	OTC MONOGRAPH DRUG
Aspirin 81 Aspirin	0363-6452	TABLET	ORAL	ASPIRIN 81 mg/1	WALGREENS	OTC MONOGRAPH DRUG
Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine	0067-2000	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Haleon US Holdings LLC	OTC MONOGRAPH DRUG
Medi-First Plus Extra Strength Non Aspirin Acetaminophen	47682-174	TABLET	ORAL	ACETAMINOPHEN 500 mg/1	Unifirst First Aid Corporation	OTC MONOGRAPH DRUG
Aspirin Regular Strength Aspirin	11822-6910	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 325 mg/1	Rite Aid Corporation	OTC MONOGRAPH DRUG
Adult Low Dose Enteric Coated Aspirin Aspirin	68071-3829	TABLET, COATED	ORAL	ASPIRIN 81 mg/1	NuCare Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
Excedrin PM Triple Action Caplets Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate	0067-2056	TABLET, COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；DIPHENHYDRAMINE CITRATE 38 mg/1	Haleon US Holdings LLC	OTC MONOGRAPH DRUG
Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine	41250-334	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Meijer Distribution Inc	OTC MONOGRAPH DRUG
Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate	53943-873	TABLET, EFFERVESCENT	ORAL	ASPIRIN 325 mg/1；PHENYLEPHRINE BITARTRATE 7.8 mg/1；CHLORPHENIRAMINE MALEATE 2 mg/1	Discount Drug Mart	OTC MONOGRAPH FINAL
Aspirin Low Dose Aspirin	79481-6450	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Meijer Distribution, Inc.	OTC MONOGRAPH DRUG
Meijer Effervescent Antacid and Pain Relief Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate	41250-222	TABLET, EFFERVESCENT	ORAL	ASPIRIN 325 mg/1；SODIUM BICARBONATE 1916 mg/1；ANHYDROUS CITRIC ACID 1000 mg/1	Meijer Distribution Inc	OTC MONOGRAPH DRUG
Headache Relief Acetaminophen, Aspirin, Caffeine	56062-934	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Publix Super Markets Inc	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate	0280-8287	KIT	ORAL	—	Bayer HealthCare LLC.	OTC MONOGRAPH DRUG
BAYER Aspirin Extra Strength Caplets BAYER Aspirin Extra Strength	0280-2020	TABLET	ORAL	ASPIRIN 500 mg/1	Bayer HealthCare LLC.	OTC MONOGRAPH DRUG
Top Value Effervescent Cold Relief - Orange Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate	50201-8752	TABLET, EFFERVESCENT	ORAL	PHENYLEPHRINE BITARTRATE 7.8 mg/1；ASPIRIN 325 mg/1；CHLORPHENIRAMINE MALEATE 2 mg/1	Tower Laboratories Ltd.	OTC MONOGRAPH DRUG
Aspirin Low Dose Aspirin	63941-600	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Valu Merchandisers Company	OTC MONOGRAPH DRUG
Pain Reliever Plus Acetaminophen, Aspirin, Caffeine	0536-1326	TABLET, FILM COATED	ORAL	ASPIRIN 250 mg/1；CAFFEINE 65 mg/1；ACETAMINOPHEN 250 mg/1	Rugby Laboratories	OTC MONOGRAPH DRUG
Thompson Extra Strength Non-Aspirin Acetaminophen	73408-274	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 500 mg/1	Thompson	OTC MONOGRAPH DRUG
migraine relief Acetaminophen, Aspirin, Caffeine	11822-0374	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Rite Aid Corporation	ANDA
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	0280-0110	KIT	—	—	Bayer HealthCare LLC.	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest aspirin, chlorpheniramine maleate, phenylephrine bitartrate	0280-0020	TABLET, EFFERVESCENT	ORAL	PHENYLEPHRINE BITARTRATE 7 mg/1；CHLORPHENIRAMINE MALEATE 2 mg/1；ASPIRIN 325 mg/1	Bayer HealthCare LLC.	OTC MONOGRAPH DRUG
Norgesic Forte Orphenadrine Citrate, Aspirin and Caffeine	50991-999	TABLET, MULTILAYER	ORAL	ORPHENADRINE CITRATE 50 mg/1；ASPIRIN 770 mg/1；CAFFEINE 60 mg/1	Poly Pharmaceuticals, Inc.	ANDA
Aspirin 81mg Enteric Coated Aspirin	55154-2607	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Cardinal Health 107, LLC	OTC MONOGRAPH DRUG
Aspirin	55301-157	TABLET, FILM COATED	ORAL	ASPIRIN 325 mg/1	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
ASPIRIN	70677-1245	TABLET	ORAL	ASPIRIN 81 mg/1	Strategic Sourcing Services LLC	OTC MONOGRAPH DRUG
Medique Products Chewable Low Dose Aspirin Aspirin	47682-038	TABLET, CHEWABLE	ORAL	ASPIRIN 81 mg/1	Unifirst First Aid Corporation	OTC MONOGRAPH DRUG
Low Dose Aspirin Aspirin	55319-601	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Family Dollar Services Inc	OTC MONOGRAPH DRUG
migraine relief acetaminophen, aspirin, caffeine	30142-896	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Kroger Company	ANDA
Green Guard Chewable Aspirin 81 mg Aspirin	47682-039	TABLET, CHEWABLE	ORAL	ASPIRIN 81 mg/1	Unifirst First Aid Corporaiton	OTC MONOGRAPH DRUG
Dollar General Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate	55910-873	TABLET, EFFERVESCENT	ORAL	ASPIRIN 325 mg/1；CHLORPHENIRAMINE MALEATE 2 mg/1；PHENYLEPHRINE BITARTRATE 7.8 mg/1	DOLGENCORP, LLC	OTC MONOGRAPH DRUG
Thompson Aspirin Aspirin	73408-618	TABLET, FILM COATED	ORAL	ASPIRIN 325 mg/1	Thompson	OTC MONOGRAPH DRUG
Excedrin Extra Strength Headache Acetaminophen, Aspirin (NSAID), Caffeine	0067-2002	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	Haleon US Holdings LLC	OTC MONOGRAPH DRUG
Aspirin	46122-791	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Amerisource Bergen	OTC MONOGRAPH DRUG
Unishield Aspirin Aspirin	49314-1163	TABLET, FILM COATED	ORAL	ASPIRIN 325 mg/1	Unishield	OTC MONOGRAPH DRUG
Aspirin 81 Aspirin	57237-302	TABLET	ORAL	ASPIRIN 81 mg/1	Rising Pharma Holdings, Inc.	OTC MONOGRAPH DRUG
Thompson Extra Strength Non-Aspirin Acetaminophen	73408-804	TABLET	ORAL	ACETAMINOPHEN 500 mg/1	Thompson	OTC MONOGRAPH DRUG
Low Dose Aspirin Aspirin	76162-980	TABLET, COATED	ORAL	ASPIRIN 81 mg/1	Topco Associates	OTC MONOGRAPH DRUG
Pain Relief Aspirin Chewable, Low Dose Aspirin	11822-0397	TABLET, CHEWABLE	ORAL	ASPIRIN 81 mg/1	Rite Aid Corporation	OTC MONOGRAPH DRUG
EXTRA STRENGTH PAIN RELIEF Acetaminophen, Aspirin, Caffeine	21130-037	TABLET	ORAL	ASPIRIN 250 mg/1；ACETAMINOPHEN 250 mg/1；CAFFEINE 65 mg/1	BETTER LIVING BRANDS, LLC	OTC MONOGRAPH DRUG
Vanquish Extra Strength acetaminophen, aspirin, and caffeine	42364-2208	TABLET, COATED	ORAL	ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1；CAFFEINE 65 mg/1	DSE Healthcare Solutions, LLC	OTC MONOGRAPH DRUG
Unishield Extra Strength Non-Aspirin Acetaminophen	49314-1763	TABLET, FILM COATED	ORAL	ACETAMINOPHEN 500 mg/1	Unishield	OTC MONOGRAPH DRUG
aspirin aspirin	53209-2000	TABLET, ORALLY DISINTEGRATING	—	ASPIRIN 325 mg/325mg	Morning Stat OTC	DRUG FOR FURTHER PROCESSING
BAYER ASPIRIN	66715-9726	TABLET	ORAL	ASPIRIN 325 mg/1	Lil' Drug Store Products, Inc.	OTC MONOGRAPH DRUG
Green Guard Extra Strength Pain Relief Aspirin. Caffeine	47682-048	TABLET, FILM COATED	ORAL	ASPIRIN 500 mg/1；CAFFEINE 32.5 mg/1	Unifirst First Aid Corporation	OTC MONOGRAPH DRUG
Unishield Extra Strength Non-Aspirin Acetaminophen	49314-1773	TABLET	ORAL	ACETAMINOPHEN 500 mg/1	Unishield	OTC MONOGRAPH DRUG
Aspirin 81mg Enteric Coated Aspirin	77333-031	TABLET, DELAYED RELEASE	ORAL	ASPIRIN 81 mg/1	Gendose Pharmaceuticals, LLC	OTC MONOGRAPH DRUG
Unishield Extra Strength Non Aspirin Acetaminophen	49314-1783	TABLET	ORAL	ACETAMINOPHEN 500 mg/1	Unishield	OTC MONOGRAPH DRUG
Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange Aspirin	0280-2080	TABLET, CHEWABLE	ORAL	ASPIRIN 81 mg/1	Bayer HealthCare LLC.	OTC MONOGRAPH DRUG
Extra Strength Pain Aid Acetaminophen, Aspirin, Caffeine	69732-006	TABLET	ORAL	CAFFEINE 65 mg/1；ACETAMINOPHEN 250 mg/1；ASPIRIN 250 mg/1	Hi-Tech Nutaceuticals, LLC	OTC MONOGRAPH DRUG
Thompson XS Pain Ache Aspirin, Caffeine	73408-821	TABLET, FILM COATED	ORAL	CAFFEINE 32.5 mg/1；ASPIRIN 500 mg/1	Thompson Safety	OTC MONOGRAPH DRUG

数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。

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