FDA.reportPublic FDA data

NDC 65517-2005-01 - DawnMist

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
65517-2005
Requested NDC
65517-2005-01
Package NDCs from labels
65517-2005-0, 65517-2005-1, 65517-2005-2, 65517-2005-3, 65517-2005-4, 65517-2005-5, 65517-2005-01
Manufacturer
Dukal LLC
Effective date
2025-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DawnMist - Dukal LLCDukal LLC2025-02-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2005-0DawnMist17 g in 1 TUBEPASTE, DENTIFRICE173
65517-2005-1DawnMist24 g in 1 TUBEPASTE, DENTIFRICE243
65517-2005-2DawnMist43 g in 1 TUBEPASTE, DENTIFRICE433
65517-2005-3DawnMist78 g in 1 TUBEPASTE, DENTIFRICE783
65517-2005-4DawnMist134 g in 1 TUBEPASTE, DENTIFRICE1343
65517-2005-5DawnMist181 g in 1 TUBEPASTE, DENTIFRICE1813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2005DAWNMIST (TOOTHPASTE) PASTE, DENTIFRICE [DUKAL LLC]3Current NDC, 6 package rows20250210_147f7738-5080-9907-e063-6294a90a6170.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 144 · 2,861 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackf28c8928-81c3-458a-9ce2-2aaca3b7527d2026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackef79cadb-c553-4af1-9a53-6ea1ab26b4bb2026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepackfe9da1e9-9b36-4702-bec2-13187f0f65482026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
DentoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, LYMPH NODE(SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA FLUORICA, NATRUM FLUORATUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMBioActive Nutritional, Inc.dbe965b3-e81e-4328-bc41-43e875e12a052026-03-18WarningsExact identifier
unii: 8ZYQ1474W7
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack6607fcec-2da9-47df-ad92-1d545f7bf5352026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack3c3acbdd-0bcb-4798-b6c5-242bdcd352b12026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack5568579f-3445-4f04-a936-33c78b33392c2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
unii: K679OBS311
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
unii: H0G9379FGK
AMAZON Ultra Strength Tropical FruitANTACID TABLETS (CALCIUM CARBONATE)AMAZON.COM SERVICES LLCdd93a70e-8b43-495e-bda3-526e5d6de9532026-03-12WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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