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 27 of 185 · 3,695 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: B697894SGQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: LMI26O6933
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
unii: 8ZYQ1474W7
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
unii: 8ZYQ1474W7
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
unii: PDC6A3C0OX
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral RinseSODIUM FLUORIDEAMD Medicom1da64824-9389-4109-bea9-b91600caf0232026-03-05WarningsExact identifier
unii: 8ZYQ1474W7
PCXX VANILLA ORANGE ONE MINUTE FMSODIUM FLUORIDERoss Healthcare Inc.5e816186-519e-606e-e053-2a91aa0a34602026-03-05Exact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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