FDA.reportPublic FDA data

NDC 64778-0396-2 - Denti-Care Denti-Freeze Topical Anesthetic Mint

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
64778-0396
Requested NDC
64778-0396-2
Package NDCs from labels
64778-0396-1, 64778-0396-2, 64778-0396-3
Manufacturer
AMD Medicom Inc.
Effective date
2020-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
10039-M Mint Topical DentiCare Pro-Freeze Topical Anesthetic GelAMD Medicom Inc.2020-12-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW5DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
tetracaine hydrochlorideACTIVE INGREDIENT5NF5D4OPCIDENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
benzocaineACTIVE MOIETYU3RSY48JW5DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
tetracaineACTIVE MOIETY0619F35CGVDENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1

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 14 of 29 · 574 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Anal Glide ExtraBENZOCAINEPRODUCT MAX GROUP INC282ac8d3-2caf-42de-b347-450e9c7a9e502025-04-03WarningsExact identifier
unii: U3RSY48JW5
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
unii: U3RSY48JW5
Thunder Fck Male Genital DesensitizerBENZOCAINEPRODUCT MAX GROUP INC93188a42-0d3c-4159-bdc7-bbc5ec5c67442025-03-06WarningsExact identifier
unii: U3RSY48JW5
Body Action Climax Guard DelayBENZOCAINEPRODUCT MAX GROUP INCf88e0b42-974e-4f46-a93b-34b06320770a2025-03-06WarningsExact identifier
unii: U3RSY48JW5
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
unii: U3RSY48JW5
Sheffield Pain ReliefBENZOCAINESheffield Pharmaceuticals LLCe21abfdd-373d-42af-9535-fe1571382a652025-02-19WarningsExact identifier
unii: U3RSY48JW5
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
unii: U3RSY48JW5
Tetracaine HydrochlorideTETRACAINE HYDROCHLORIDEA-S Medication Solutions23c40ef8-6338-46f8-aca9-1aa4f3b2207b2025-02-11Warnings, Adverse reactionsExact identifier
unii: 5NF5D4OPCI
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
unii: U3RSY48JW5
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCb291811f-8fac-45e2-a9a2-b3ecc0813d0d2025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCfea30599-5e3b-4163-9660-d41b3fcee1432025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC3be68966-199c-481e-8b9e-e994c41fd96a2025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCccdee0cc-2bc9-4165-a411-02f4f900d86a2025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b72025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC69c4dd1b-a0db-4495-bfc3-faffdfdf59bf2025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCd5ef3e65-35e8-4323-9f33-3076b561e1052025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC746df21c-e92e-4a71-b1c6-baf99785a43e2025-01-29WarningsExact identifier
unii: U3RSY48JW5
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC2345e614-c7b6-448c-8e07-31700bade91c2025-01-29WarningsExact identifier
unii: U3RSY48JW5
UltraCare Anesthetic GelBENZOCAINEThe Belport Company, Inc. DBA Gingi-Pak142062ca-6f8f-78d2-e063-6294a90a19d82025-01-29Warnings, Adverse reactionsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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