FDA.reportPublic FDA data

NDC 0135-0613 - AQUAFRESH whitening intense white

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
0135-0613
Package NDCs from labels
0135-0613-01
Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AQUAFRESH whitening intense white - Haleon US Holdings LLCHaleon US Holdings LLC2024-04-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0613-01AQUAFRESH whiteningwhite and shine121.9 g in 1 TUBEPASTE121.94
0135-0613-01AQUAFRESH whiteningwhite and shine1 in 1 CARTONPASTE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0613AQUAFRESH WHITENING INTENSE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING WHITE AND SHINE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]42 package rows20240426_8baed730-f9a1-40ea-83fc-dcc6bd0ac62f.zip

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 144 of 179 · 3,580 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelato Neutral pHSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.2dda92cc-2e50-4fa8-a214-714750943b002024-04-22WarningsExact identifier
unii: 8ZYQ1474W7
Gelato Neutral pHSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc738c98a9-6549-4179-8758-fc026c61c3722024-04-22WarningsExact identifier
unii: 8ZYQ1474W7
Gelato Neutral pHSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc2f8fe488-4a1b-451a-852b-4ddc2cf083472024-04-22WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.27a7905a-110e-46ce-803d-9c75a530c8382024-04-19WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride and Potassium NitrateSODIUM FLUORIDE AND POTASSIUM NITRATEWestminster Pharmaceuticals, LLC7a051d80-879d-4995-96ef-77b60dad26b72024-04-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Navajo Manufacturing Company Inc.a70751ff-a313-49a7-e053-2a95a90a54472024-04-15WarningsExact identifier
unii: B697894SGQ
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
unii: 8ZYQ1474W7
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
MotivationDIOSCOREA VILLOSA, LECITHIN, SEPIA, VIOLA ODORATA, ADRENALINUM, LITHIUM CARBONICUM, THYROIDINUM (BOVINE), PLACENTA TOTALIS SUIS, GUAIACUM, SOLANUM TUBEROSUM, ANTIMONIUM CRUDUM, AURUM SULPHURATUM, BARYTA CARBONICA, CHININUM SULPHURICUM, CONIUM MACULATUM, GRAPHITES, LILIUM TIGRINUM, RHUS VENENATA, SELENIUM METALLICUM, ALUMINADeseret Biologicals, Inc.c2bb0fb2-7ffa-4d16-8fff-b4c3dde966f42024-04-01WarningsExact identifier
unii: LMI26O6933
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
unii: 8ZYQ1474W7
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
unii: 8ZYQ1474W7
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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