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 98 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HormoslimCALC CARB, NUX VOM, SEPIA, SPONGIA, SULPHURSilver Star Brandsd5f3c0a7-248b-8c0b-e053-2a95a90a0d302025-01-01WarningsExact identifier
unii: H0G9379FGK
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
unii: 8ZYQ1474W7
DUAL ACTION Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLELil' Drug Store Products, Inc.f3cf2e19-1348-0eac-e053-2a95a90a46c12024-12-30WarningsExact identifier
unii: H0G9379FGK
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCaf7a5768-7d1d-3d93-e053-2a95a90a38f62024-12-29WarningsExact identifier
unii: K679OBS311
TruGuard 5000SODIUM FLUORIDE TOOTHPASTEThe Atlanta Dental Supply Company DBA Advanced Dental Products3b8efdcf-5beb-46c2-b118-64940a7fc74b2024-12-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
rxcui: 245598
unii: 8ZYQ1474W7
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
unii: H0G9379FGK
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
unii: H0G9379FGK
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
unii: H0G9379FGK
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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