NDC 82500-010-01 - Hellotis Mouthwash

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
82500-010
Requested NDC
82500-010-01
Package NDCs from labels
82500-010-01, 82500-010-02
Manufacturer
iONEBIO INC. | ECOWORLDPHARM CO .,LTD
Effective date
2022-01-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hellotis Mouthwash - iONEBIO INC. | ECOWORLDPHARM CO .,LTDiONEBIO INC. | ECOWORLDPHARM CO .,LTD2022-01-11HUMAN OTC 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 59 of 60 · 1,192 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sodium Fluoride 5000 ppm SensitiveSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC02f4cf0b-188c-4522-b759-ffe4a9d150e82020-04-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PreviDent 5000 SensitiveSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.b028cfff-4946-49e8-b8bb-197ab99d0d352019-12-09Warnings, Adverse reactionsExact 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

Reported adverse events (FAERS/openFDA)#

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