LolliCaine Mint

Product NDC
60640-9200
11-digit product format
606409200
Labeler code
60640
Product ID
60640-9200_41ee7ce6-1b54-c719-e063-6394a90a48ca
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Centrix, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-14
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60640-9200-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60640-9200-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60640-9200-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60640-9200-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60640-9200-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60640-9200-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60640-9200-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60640-9200-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60640-9200-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60640-9200-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60640-9200-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60640-9200-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60640-9200-11332a3947898…d4bfe170f9cd…

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
LolliCaine Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup
1942189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56ae3a84-6bca-4906-a03d-9d755e1fba3bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60640-9200-1LolliCaine Mint120 in 1 CARTONGEL, DENTIFRICE1206
60640-9200-1LolliCaine Mint0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60640-9200-1EA - Each60640-92008aed0cd4-c527-4de6-860f-028cf12225d212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60640-9200LOLLICAINE BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE CHERRY (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE MINT (BENZOCAINE) GEL, DENTIFRICE LOLLICAINE PINA COLADA (BENZOCAINE) GEL, DENTIFRICE [CENTRIX, INC.]3Current NDC, Legacy NDC, 2 package rows20250519_56ae3a84-6bca-4906-a03d-9d755e1fba3b.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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 20 % Oral GelPSN56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189benzocaine 0.2 MG/MG Oral Gel [LolliCaine]SBD56ae3a84-6bca-4906-a03d-9d755e1fba3b6
238910benzocaine 0.2 MG/MG Oral GelSCD56ae3a84-6bca-4906-a03d-9d755e1fba3b6
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 0.2 MG/MG Oral GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6
1942189LolliCaine 20 % Dental GelSY56ae3a84-6bca-4906-a03d-9d755e1fba3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60640-9200-160640920001120 DOSE PACK in 1 CARTON (60640-9200-1) / .4 g in 1 DOSE PACK120 dose pack2019-01-140000-00-00NoNoCurrent