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 11 of 185 · 3,695 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
unii: 8ZYQ1474W7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
PreviDent 5000 Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals Inc.5ef93306-59dd-447b-a2ec-dd865e52c76b2026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Booster Plus SpearmintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.4ef2b7ed-41c3-41cb-8ee0-1930ab8fb1982026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent Alcohol FreeSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c02026-06-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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