Mouth Rinse
sodium fluoride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1450758 | 1450758 | TOPPAN TEQ LLC | 1 | N | 2026-01-01 | 11287 Kiley Drive Huntley IL US 60142 |
| 2084960 | 1000135819 | Top Quality Manufacturing, LLC | 1 | Y | 2026-01-01 | 28703 INDUSTRY DR Valencia CA US 91355 |
| 2242863 | 2242863 | Topcon Healthcare, Inc. | 1 | Y | 2026-01-01 | 111 Bauer Dr Oakland NJ US 07436 |
| 2523318 | 2523318 | TOP QUALITY MANUFACTURING, LLC | 1 | Y | 2026-01-01 | 800 Primos Avenue Folcroft PA US 19032 |
| 3001106688 | 3001106688 | Top Safety Products, Inc. | 1 | N | 2026-01-01 | 160 Meister Ave Ste 16 Branchburg NJ US 08876 |
| 3002715552 | 3002715552 | TOP BRASS, INC. | 1 | N | 2026-01-01 | 1001 E Mohawk St Wittenberg WI US 54499 |
| 3003772414 | 3003772414 | TOP LONGMAX PRODUCTS CO., LTD. | 1 | N | 2026-01-01 | 28, SHIH CHENG S. 1ST., RD TAICHUNG TW 407 |
| 3003890514 | 3003890514 | TOP SHELF MANUFACTURING, LLC | 1 | N | 2026-01-01 | 1851 E. PARADISE ROAD, SUITE A Tracy CA US 95304 |
| 3007127364 | 3007127364 | TOP MEDICAL CORP. | 1 | N | 2026-01-01 | 2F, No. 114, Bai-Ma Street Chung Li City Taoyuan TW 320 |
| 3007253950 | 3007253950 | Top Quality Manufacturing, LLC | 1 | Y | 2026-01-01 | 13165 Sandoval St Santa Fe Springs CA US 90670 |
| 3010975837 | 3010975837 | TOPARC TECHNOLOGY (SHENZHEN) CO.,LTD | 1 | N | 2026-01-01 | Nbr. 101; 1-4 Floors of Workshop; Nbr 23-1 Longteng Road Baoan Community Yuanshan Street; Shenzhen, GUANG Shenzhen Guangdong CN 518115 |
| 3011308135 | 3011308135 | TOPWIDE (HUBEI) MEDICAL PRODUCTS MANUFACTURER | 1 | N | 2026-01-01 | 19 Xianhong Road, Xin Li Ren Kou Xiantao Hubei CN 433012 |
| 3011500374 | 3011500374 | TOP CORPORATION OHMASU PLANT | 1 | N | 2026-01-01 | 1-5 OHMASU, ISHIOKA Ibaraki JP 315-0101 |
| 3017958535 | 3017958535 | TOPWELL GROUP UNIT CO., LTD. | 1 | N | 2026-01-01 | NO.1, South 5th Street, Building 3, Heshi Road, Qiaotou Town Dongguan City Guangdong CN 523527 |
| 3027307208 | 3027307208 | TOPWAY SPORTS ENTERPRISE CO LTD | 1 | N | 2026-01-01 | LAND PLOT NO 114, MAPNP 11, VINH TAN 21 STREET GROUP NO 4, QUARTER NO 4, VINH TAN WARD TAN UYEN TOWN Binh Duong VN 25309 |
| 3027341558 | 3027341558 | TOPZIR BIOTECH CO., LTD | 1 | N | 2026-01-01 | Room 520, Creative Center, No.69, Guangpu West Road, Huangpu Dis Guangzhou Guangdong CN 510663 |
| 3027694073 | 3027694073 | TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED | 1 | N | 2026-01-01 | 5Vsip II Street No 7, Viet Nam-Singapore II Industrial Zone, Bin Hoa Phu Ward Thu Dau Mot Binh Duong VN 820000 |
| 3039169546 | 3039169546 | TOPMED MEDICAL DEVICES INC | 1 | Y | 2026-01-01 | 16 Goddard Irvine CA US 92618 |
| 3042366049 | 3042366049 | TOPMD SKIN CARE, INC. | 1 | N | 2026-01-01 | 1511 Prudential Dr Dallas TX US 75235 |
| 3042471840 | 3042471840 | TOPTOLIFE DIAGNOSTICS LLC | 1 | Y | 2026-01-01 | 4023 Kennett Pike #50076 Wilmington DE US 19807 |
| 3042894943 | 3042894943 | Toppro International Co., Ltd. | 1 | N | 2026-01-01 | 1469/6 Soi Pattanakarn 31/1, Pattanakarn Road, Suanluang Bangkok Krung Thep Maha Nakhon TH 10250 |
| 3043494619 | 3043494619 | TOPIA MEDTECH LIMITED | 1 | N | 2026-01-01 | 2 Falcon Gate, Shire Park, Welwyn Garden City Herefordshire GB AL7 1TW |
| 0 | 0 | TOP'S HEALTHCARE PRODUCT INC. | 5 | Y | 2020-04-25 | 2231 East 49th St, Vernon, CA, 90058 Vernon CA US 90058 |
| 0 | 0 | TOPGRADE PRODUCTS INC | 5 | Y | 2020-04-25 | 56-02 MASPETH AVENUE Maspeth NY US 11378 |
| 3004215984 | 3004215984 | TOP-SERVICE FUER LINGUALTECHNIK GMBH | 1 | N | 2020-04-25 | Schledehauser Str. 81 BAD ESSEN, LOWER SAXONY Niedersachsen DE 49152 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 238249 | 1116790014 | K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | FMF | 1984-12-07 |
| 347247 | 2003278346 | K252670 | Alzevita | QIH | 2025-12-19 |
| 36281 | 1194849754 | K232555 | Harmony | NFJ | 2023-11-20 |
| 316334 | 1068872907 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | 2023-03-31 |
| 341057 | 1110928162 | K221745 | Sterile Posterior Spinal Fixation System | NKB | 2022-08-31 |
| 341057 | 1298318679 | K201737 | Posterior Spinal Fixation System | NKB | 2021-06-21 |
| 347216 | 1857875677 | K191898 | Sterile Latex Powder-Free Surgical Gloves | KGO | 2019-12-18 |
| 345145 | 1823648989 | K190054 | BD Insulin Syringe | FMF | 2019-10-21 |
| 36281 | 1930111968 | K182376 | Harmony | NFJ | 2018-09-28 |
| 36281 | 1732363706 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 |
| 346182 | 1794350763 | K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | KHE | 2017-05-14 |
| 36281 | 2034869577 | K151952 | Synergy ODM | NFJ | 2015-10-01 |
| 61334 | 1580206283 | K142491 | ZEL TIQ CoolSculpting System | OOK | 2015-01-26 |
| 344149 | 1816069519 | K133542 | PURACYN PLUS SKIN AND WOUND | FRO | 2014-04-28 |
| 346182 | 1894822748 | K133343 | WONDFO RAPID STREP A TEST | GTY | 2014-01-31 |
| 346182 | 2070147338 | K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | JIO | 2012-04-17 |
| 113514 | 1688734191 | K083418 | CPR MASK | CBP | 2010-07-22 |
| 346182 | 1453947931 | K072500 | ONE STEP HCG URINE/SERUM TEST | DHA | 2009-04-21 |
| 16547 | 1015631173 | ||||
| 16547 | 1092797764 | ||||
| 190879 | 1131544839 | ||||
| 91801 | 1139408117 | ||||
| 194798 | 1192783464 | ||||
| 16547 | 1293206662 | ||||
| 16547 | 1301831981 | ||||
| 257556 | 1328446037 | ||||
| 91801 | 1335817097 | ||||
| 194798 | 1473948854 | ||||
| 16547 | 1505754812 | ||||
| 91801 | 1521827323 | ||||
| 16547 | 1629348963 | ||||
| 194798 | 1640817876 | ||||
| 16547 | 1682835018 | ||||
| 16547 | 1753673429 | ||||
| 16547 | 1868305611 | ||||
| 194798 | 1896222144 | ||||
| 91801 | 1905480519 | ||||
| 16547 | 1989440265 | ||||
| 38401 | 1999765005 | ||||
| 93341 | 1999765005 | ||||
| 16547 | 2030987726 | ||||
| 91801 | 2043369313 | ||||
| 61334 | 1000123083 | ||||
| 190879 | 1003076482 | ||||
| 61334 | 1005882253 | ||||
| 113514 | 1009073530 | ||||
| 176076 | 1010296594 | ||||
| 61334 | 1015019220 | ||||
| 341057 | 1028218588 | ||||
| 16547 | 1028939000 | ||||
| 16547 | 1065913974 | ||||
| 61334 | 1089359306 | ||||
| 113514 | 1098441827 | ||||
| 153525 | 1100082046 | ||||
| 176076 | 1101202137 | ||||
| 285126 | 1103631560 | ||||
| 285504 | 1144338358 | ||||
| 61334 | 1174095103 | ||||
| 285504 | 1175873922 | ||||
| 176076 | 1182323375 | ||||
| 91801 | 1189791975 | ||||
| 316990 | 1203563831 | ||||
| 16547 | 1208421255 | ||||
| 61334 | 1215421825 | ||||
| 285504 | 1244175697 | ||||
| 345145 | 1254518963 | ||||
| 61334 | 1271763987 | ||||
| 61334 | 1320548220 | ||||
| 61334 | 1337602436 | ||||
| 341057 | 1346916154 | ||||
| 316990 | 1378782057 | ||||
| 61334 | 1404210100 | ||||
| 36281 | 1418566269 | ||||
| 61334 | 1433933947 | ||||
| 341057 | 1436903639 | ||||
| 341057 | 1444674036 | ||||
| 341057 | 1453154111 | ||||
| 91801 | 1461517858 | ||||
| 16547 | 1470344404 | ||||
| 61334 | 1474735145 | ||||
| 16547 | 1476562406 | ||||
| 36281 | 1478020805 | ||||
| 285126 | 1485362952 | ||||
| 113514 | 1490658483 | ||||
| 341057 | 1514940476 | ||||
| 341057 | 1549629963 | ||||
| 113514 | 1552840134 | ||||
| 91801 | 1590500599 | ||||
| 36281 | 1592933023 | ||||
| 341057 | 1600370251 | ||||
| 36281 | 1605514848 | ||||
| 285504 | 1651199845 | ||||
| 61334 | 1652011257 | ||||
| 113514 | 1658222346 | ||||
| 341057 | 1659599497 | ||||
| 61334 | 1668265879 | ||||
| 113514 | 1685093511 | ||||
| 113514 | 1718357349 | ||||
| 61334 | 1728441577 | ||||
| 91801 | 1747246271 | ||||
| 61334 | 1754748517 | ||||
| 190879 | 1772788830 | ||||
| 36281 | 1795210075 | ||||
| 341057 | 1829407292 | ||||
| 61334 | 1835726848 | ||||
| 341057 | 1840376843 | ||||
| 36281 | 1844136882 | ||||
| 91801 | 1844737539 | ||||
| 341057 | 1850372757 | ||||
| 341057 | 1854814902 | ||||
| 61334 | 1864678966 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NFJ | 4 | 2023-11-20 |
| NKB | 2 | 2022-08-31 |
| FMF | 2 | 2019-10-21 |
| QIH | 1 | 2025-12-19 |
| EIH | 1 | 2023-03-31 |
| KGO | 1 | 2019-12-18 |
| KHE | 1 | 2017-05-14 |
| OOK | 1 | 2015-01-26 |
| FRO | 1 | 2014-04-28 |
| GTY | 1 | 2014-01-31 |
| JIO | 1 | 2012-04-17 |
| CBP | 1 | 2010-07-22 |
| DHA | 1 | 2009-04-21 |
sodium fluoride
SODIUM FLUORIDE
Liquid Corn and Callus Remover
Antifungal Liquid Spray
Salicylic acid
POVIDONE-IODINE
Lanolin, Petrolatum
Hydrocortisone
Medicated Callus Removers
Zinc oxide
Medicated Corn Removers
Foot Odor Control Spray
Nicotine Polacrilex
Burn Relief
Nicotine Transdermal System
Nicotine Transdermal System
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Nicotine Transdermal System
Witch hazel
PHENAZOPYRIDINE HYDROCHLORIDE
Wart Remover Gel
Butenafine Hydrochloride
diphenhydramine citrate and ibuprofen
Hydrocortisone
Pseudoephedrine Hydrochloride
Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
ibuprofen
FERRIC OXIDE RED
Isopropyl Alcohol
White Petrolatum
Eucalyptol, Menthol, Methyol salicylate, Thymol
Isopropyl alcohol
Miconazole nitrate
Famotidine, Calcium Carbonate, Magnesium Hydroxide
docusate sodium and sennosides
Pyrithione Zinc
Adapalene
Bacitracin Zinc
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
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