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 52 of 53 · 1,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ionite RSODIUM FLUORIDEDharma Research, Inc.0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a52020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.d22afac7-45d6-467e-951a-e7c241b9180d2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.4828b482-486f-4105-bed0-3fe2ddbbddb12020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, Inc.8987b447-3fa3-4f52-aecc-80e44c981aaa2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.8191554f-adb6-4ba9-aa80-0a9bb65193ec2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.ddd34623-cb79-4fa7-bd01-19122470b63d2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careae45ae2d-a21f-0a05-e053-2995a90a4d5e2020-09-01WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Careae32b0a2-e42f-6a56-e053-2a95a90a0b002020-08-31WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm SensitiveSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC02f4cf0b-188c-4522-b759-ffe4a9d150e82020-04-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 SensitiveSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.b028cfff-4946-49e8-b8bb-197ab99d0d352019-12-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC21fa26f2-0162-4044-aec0-d5360be3f3e02019-03-28WarningsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.5fd60635-4b66-15e3-e053-2991aa0ab23a2019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Pro-Den RxSODIUM FLUORIDEDen-mat Holdings, Llce39b19f7-2b3e-4c77-9544-623ebad848702019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.6014c330-3698-027c-e053-2a91aa0a64e52019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Pro-Den RxSODIUM FLUORIDEDen-Mat Holdings, Llcba020e07-ad41-4419-a503-f1245131b7d22018-04-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
unii: 8ZYQ1474W7
SF1.1% SODIUM FLUORIDECypress Pharmaceutical, Inc.b7c0a768-7e8a-40b9-876f-b86d3dc5e8482016-07-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
SF 5000 Plus1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAMCypress Pharmaceutical, Inc.fa625ece-d873-491a-8d45-2833b64e54252016-07-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite HSODIUM FLUORIDE, POTASSIUM NITRATEDharma Research, Inc.54c1a27c-5936-4ee2-a419-3891d3df97452015-08-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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