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#

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 29 of 29 · 573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
unii: U3RSY48JW5
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
unii: U3RSY48JW5
Cetacaine Topical AnestheticBENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDECetylite Industries, Inc.9777acbb-8166-4734-9932-dc66b05bfcb52022-01-17WarningsExact identifier
unii: U3RSY48JW5
unii: 5NF5D4OPCI
Cetacaine AnestheticBENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDECetylite Industries, Inc.af1773c5-5d5b-4278-b551-30ad2df6d5b52022-01-17WarningsExact identifier
unii: U3RSY48JW5
unii: 5NF5D4OPCI
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
unii: U3RSY48JW5
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
unii: U3RSY48JW5
b60e7299-46f9-6c6e-e053-2a95a90ae09681551489-c68a-4d2d-b07b-333ead22e8f12020-12-09WarningsExact identifier
spl id: b60e7299-46f9-6c6e-e053-2a95a90ae096
spl set id: 81551489-c68a-4d2d-b07b-333ead22e8f1
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
unii: U3RSY48JW5
PreboostBENZOCAINEThe Female Health Company d/b/a Veru Healthcare155e4ba2-7f06-454e-ae7e-e55ef8f891e32017-04-07WarningsExact identifier
unii: U3RSY48JW5
CVS Pharmacy Sensitive Medicated CreamBENZOCAINE, BENZALKONIUM CHLORIDECVS Pharmacy454c3458-7e40-0e5e-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: U3RSY48JW5
Dental ReliefBENZOCAINECintas First Aid & Safetyd9068a54-6123-4715-b025-a5bdb4d5c7022014-02-27WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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