FDA.reportPublic FDA data

NDC 64778-0394-2 - Denti-Care Denti-Freeze Topical Anesthetic Cherry

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
64778-0394
Requested NDC
64778-0394-2
Package NDCs from labels
64778-0394-1, 64778-0394-2, 64778-0394-3
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-CH Cherry 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 CHERRY (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
tetracaine hydrochlorideACTIVE INGREDIENT5NF5D4OPCIDENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC CHERRY (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
benzocaineACTIVE MOIETYU3RSY48JW5DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC CHERRY (BENZOCAINE, TETRACAINE HYDROCHLORIDE) GEL [AR MEDICOM INC]1
tetracaineACTIVE MOIETY0619F35CGVDENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC CHERRY (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 1 of 29 · 574 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: U3RSY48JW5
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: U3RSY48JW5
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: U3RSY48JW5
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: U3RSY48JW5
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: U3RSY48JW5
Tetracaine HydrochlorideTETRACAINE HYDROCHLORIDEREMEDYREPACK INC.01fba5f8-a60a-444c-9abd-299540b8815a2026-08-28Warnings, Adverse reactionsExact identifier
unii: 5NF5D4OPCI
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
unii: U3RSY48JW5
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
unii: U3RSY48JW5
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
unii: U3RSY48JW5
Alphamale Delay CreamBENZOCAINEProdigy Media Inc53d682ee-0802-a16d-e063-6394a90aeee12026-07-31WarningsExact identifier
unii: U3RSY48JW5
Pure Primal Delay CreamBENZOCAINEProdigy Media Inc57e9e894-c14f-d806-e063-6394a90ab8e52026-07-31WarningsExact identifier
unii: U3RSY48JW5
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
unii: U3RSY48JW5
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
unii: U3RSY48JW5
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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