AutoBrush Mint

Product NDC
82913-004
11-digit product format
829130004
Labeler code
82913
Product ID
82913-004_47433424-5a70-96b0-e063-6394a90a269f
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
LIQUID
Route
ORAL
Labeler
Lander Enterprises, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
SODIUM FLUORIDE
Active strength
.24 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct82913-004UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82913-00482913-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
AutoBrush Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6bcd35f5-18ea-4fc8-84cd-06db73f38a1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82913-004-01AutoBrush Mint1 in 1 CARTONLIQUID15
82913-004-01AutoBrush Mint50 mL in 1 BOTTLE, PLASTICLIQUID505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82913-004AUTOBRUSH MINT (SODIUM FLUORIDE) LIQUID [LANDER ENTERPRISES, LLC]4Current NDC, Legacy NDC, 2 package rows20250223_6bcd35f5-18ea-4fc8-84cd-06db73f38a1e.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 33 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag229a7feb-c646-4557-85e5-0832682ab9262024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag0e135eb0-4a40-4930-ade4-fb7df87db1f42024-12-05WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola Ag73d767e2-bb80-4eff-8420-500c2a4067aa2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag951e9836-e6a3-4094-8a6b-f226c85c897a2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
application number: M022
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
application number: M022
Orajel 2x Gum Pain Alcohol-FreeMENTHOL AND HYDROGEN PEROXIDEChurch & Dwight Co., Inc.adf37010-922c-4441-93d6-1e1a95025e902024-11-27WarningsExact identifier
application number: M022
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
application number: M022
Peroxyl Mouth Sore Mild MintHYDROGEN PEROXIDEColgate Oral Pharmaceuticals Inc.b1e1b7c9-dea7-4d64-b6a8-5343f41763592024-11-25WarningsExact identifier
application number: M022
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
application number: M022
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
application number: M022
Sore ThroatPHENOLSafeway, Inc.f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d2024-11-14WarningsExact identifier
application number: M022
Sore Throat Relief CherryPHENOLBest Choice (Valu Merchandisers Company)c0a47d59-3e15-453d-97a7-d626e86508622024-11-14WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82913-004-01829130004011 BOTTLE, PLASTIC in 1 CARTON (82913-004-01) / 50 mL in 1 BOTTLE, PLASTIC2022-12-010000-00-00NoNoCurrent