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 33 of 62 · 1,227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
Chigg AwayBENZOCAINEPierson Laboratories, Inc.8372e7c1-f145-4bc5-85ab-cf831abe70ce2025-07-24WarningsExact identifier
unii: U3RSY48JW5
Chigg AwayBENZOCAINEPharma Nobis, LLCe42fa1c6-d804-630f-e053-2995a90add6b2025-07-24WarningsExact identifier
unii: U3RSY48JW5
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
unii: G2M7P15E5P
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: U3RSY48JW5
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
unii: G2M7P15E5P
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
unii: U3RSY48JW5
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
unii: G2M7P15E5P
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022

Reported adverse events (FAERS/openFDA)#

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