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 100 of 181 · 3,620 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
unii: 15FIX9V2JP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Allday 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared92b84db-2202-33cc-e053-2a95a90a17532025-09-23WarningsExact identifier
unii: 8ZYQ1474W7
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
unii: 8ZYQ1474W7
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
unii: 8ZYQ1474W7
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
unii: 8ZYQ1474W7
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Cared9f232c0-d154-536b-e053-2995a90af37d2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared9e462d9-f0fd-4168-e053-2995a90a95b22025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careac24342d-382e-6fc2-e053-2a95a90acd692025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careadf0c686-e6a1-03f5-e053-2a95a90ac7552025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careadf22ce4-b567-5274-e053-2a95a90a85362025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: LMI26O6933
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
unii: 15FIX9V2JP
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
unii: 15FIX9V2JP
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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