NDC 0404-9405-01 - Acclean 60 Second Fluoride Treatment

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0404-9405
Requested NDC
0404-9405-01
Package NDCs from labels
0404-9405-01, 0404-9405-03
Manufacturer
Henry Schein Inc.
Effective date
2018-12-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
104-6401 Grape Henry Schein Acclean 60 Second Fluoride Treatment Gel 1.23% APFHenry Schein Inc.2018-12-25HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 51 of 53 · 1,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.b1d799c6-e483-44fd-b07c-94ca2ee239ef2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.c33e0e2e-7c68-4908-8bd4-6a3669c8774b2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC427f25e6-e50a-407a-a6f0-512123e381e42021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
Wentworth Alcohol FreeSODIUM FLUORIDESheffield Pharmaceuticals LLC5ed816ef-20bc-49ac-9202-8fac1edac5792021-03-23Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Dry MouthSODIUM FLUORIDESheffield Pharmaceuticals LLCcbc67f03-55c4-4781-ba37-87c737b602822021-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, Inc.ab9b07ad-f6b2-4289-bec4-fec58270dc972021-02-20WarningsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.4749dce1-c0b9-4737-8a30-85cd58aba21b2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.184bbe52-3909-45f6-b4d0-fe7849fabc1c2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Enamel ProtectSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC83dfdead-4f71-404e-90ae-dbd6849c7cf12021-01-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
b60dbd9d-2cbf-5968-e053-2a95a90ac8984967da0b-eb45-279b-e054-00144ff8d46c2020-12-09WarningsExact identifier
spl set id: 4967da0b-eb45-279b-e054-00144ff8d46c
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.ad7a660b-274c-417e-bdf3-1d5addf06ad12020-11-18WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.8ff1b377-0535-4548-a109-f9f1a43b85b72020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e6c31330-43e0-4d32-af54-ff852af39cab2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.bc9664df-c4eb-4d29-b1c0-4d4dff6a75e42020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.b8b7f9b8-ff11-4a76-ab36-7822c15e18922020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e1797adf-4665-4322-a3aa-dd2da9dcd3a82020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.ce34c159-34cd-47c7-937f-743b3309742b2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.503ca71a-f50c-4406-b925-5b6ac36a92122020-11-15WarningsExact identifier
unii: 8ZYQ1474W7
Ionite RSODIUM FLUORIDEDharma Research, Inc.1009afc7-6e9d-417f-a702-f8a941e084842020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.