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 10 of 144 · 2,861 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
unii: H0G9379FGK
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
unii: H0G9379FGK
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCa2ef8424-7d80-42b0-a01e-f378f629b2b62026-07-24WarningsExact identifier
unii: H0G9379FGK
MySweetSmile Strawberry Toothpaste.MYSWEETSMILE STRAWBERRY TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cf338-2c98-2770-e063-6294a90a13762026-07-24WarningsExact identifier
unii: 8ZYQ1474W7
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: K679OBS311
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED962ced24-0fb3-4aba-b32e-2e6fa1c1c5d72026-07-22WarningsExact identifier
unii: H0G9379FGK
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
unii: H0G9379FGK
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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