FDA.reportPublic FDA data

NDC 55346-2902-01 - Alpha-Caine Topical Anesthetic

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
55346-2902
Requested NDC
55346-2902-01
Package NDCs from labels
55346-2902-1, 55346-2902-01
Manufacturer
Dental Technologies, Inc.
Effective date
2025-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alpha-Caine Drug Facts, MintDental Technologies, Inc.2025-11-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-2902-1Alpha-CaineTopical Anesthetic30 g in 1 BOTTLE, PLASTICGEL309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-2902ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]8Current NDC, Legacy NDC, 1 package rows20231216_ae628766-25b7-4b4f-abb8-a43faf2f44b9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
BenzocaineACTIVE MOIETYU3RSY48JW5ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]5

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 54 of 62 · 1,221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Promescent Delay WipesBENZOCAINEAbsorptionf0a5b6be-acc5-473c-9054-b9534e769db12024-02-20WarningsExact identifier
unii: U3RSY48JW5
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
unii: U3RSY48JW5
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
unii: U3RSY48JW5
Walgreens Boil Pain ReliefBOIL PAIN RELIEFWalgreens Companyd11bd769-68d0-4057-bc2a-72719f16011e2024-02-12WarningsExact identifier
unii: U3RSY48JW5
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINESafetec of America, Inc.458e65f2-826d-4550-8c7d-17add2d7ba9a2024-02-07WarningsExact identifier
unii: U3RSY48JW5
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC02f81a86-bec5-4e8b-bddb-d463ae2ea9e92024-02-07WarningsExact identifier
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsExact identifier
unii: G2M7P15E5P
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Visine Red Eye Hydrating Comfort, CVPTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPSLil' Drug Store Products, Inc.0f50bcc8-3658-8c2c-e063-6294a90a8e132024-01-19WarningsExact identifier
unii: B697894SGQ
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
unii: U3RSY48JW5
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
unii: U3RSY48JW5
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022

Reported adverse events (FAERS/openFDA)#

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