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 70 of 141 · 2,805 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates LLC2677ca2b-b211-475e-a9c4-643fd54a744f2025-11-08WarningsExact identifier
unii: H0G9379FGK
TopCare Antacid CalciumCALCIUM CARBONATETopco Associates LLCb94eac38-62d0-49a2-bb49-053fda8129e22025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC04b3d397-df99-44e2-a191-6e9199b083982025-11-08WarningsExact identifier
unii: H0G9379FGK
topcare Antacid Calcium Ultra StrengthCALCIUM CARBONATETopco Associates LLC6e2788b3-1e33-4908-aa2c-475d69b94ee62025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare antacid calciumCALCIUM CARBONATETopco Associates LLCad001c7f-cd3f-4577-a793-50055e4327472025-11-08WarningsExact identifier
unii: H0G9379FGK
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Spongia AurumSPONGIA AURUMUriel Pharmacy Inc.fd805960-dfb5-4370-956a-873cf13115212025-11-07WarningsExact identifier
unii: H0G9379FGK
Ananassa ResinaANANASSA RESINAUriel Pharmacy Inc.52a18d0a-2c97-4e81-81ff-c836582d0a4c2025-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PCXX CREME DE MENTHE APF GSODIUM FLUORIDERoss Healthcare Inc.8281bc97-3816-8653-e053-2991aa0a0f502025-11-06Exact identifier
unii: 8ZYQ1474W7
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
PCXX GRAPE APF GSODIUM FLUORIDERoss Healthcare Inc.82872a07-04b7-5263-e053-2a91aa0aa2c22025-11-06Exact identifier
unii: 8ZYQ1474W7
PCXX VANILLA ORANGE NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.82978289-4943-83b1-e053-2991aa0a63652025-11-06Exact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS GRAPEFLUORIDE TREATMENTRoss Healthcare Inc.9c40dff1-ff82-44b3-98e5-7f9cbfd1dad62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RMS BUBBLEGUMFLUORIDE TREATMENTRoss Healthcare Inc.37f90a0f-2c67-456b-997e-8a8a4f5f09d32025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS PEPPERMINTFLUORIDE TREATMENTRoss Healthcare Inc.8532d4d9-c960-0051-e053-2a91aa0ad1a62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLC37e6a3f6-5261-475d-a7d4-e728540889822025-11-05WarningsExact identifier
unii: H0G9379FGK
WALGREENS EXTRA STRENGTH SMOOTH ANTACIDCALCIUM CARBONATEWALGREENS CO.9a5631e8-4287-4368-bb56-3ce22a3680d82025-11-04WarningsExact identifier
unii: H0G9379FGK
up and up extra strength antacid 750 Assorted BerryANTACID TABLETSTarget Corporation46f11acf-a968-4fdd-8755-3eff0b9b67d02025-11-04WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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