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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
application number: M022
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
application number: M022
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESIN1169566442981217f-f250-c090-e063-6294a90a85b02024-12-17WarningsExact identifier
application number: M022
Kank-A Mouth PainBENZOCAINEBlistex Inc.eebc03ba-f849-4e70-a653-834f383b6aa42024-12-17WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8282a4a6-b77c-75fc-e053-2991aa0ad4ac2024-12-16WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.9452bff4-8c08-eff9-e053-2a95a90a67ed2024-12-16WarningsExact identifier
application number: M022
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
application number: M022
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8281700c-10f9-841c-e053-2991aa0a918f2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.82824416-80de-76bd-e053-2a91aa0ad8b52024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.e3da0e63-a891-72bd-e053-2a95a90a58bc2024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories, Inc.e3d924b5-0788-46d3-e053-2995a90a027b2024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.763e8234-60be-4b1f-9f78-01c574f35d0a2024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.989f8509-cd28-48e7-9aa1-baddfbcac95a2024-12-10WarningsExact 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