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 31 of 62 · 1,227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsExact identifier
unii: G2M7P15E5P
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsExact identifier
unii: G2M7P15E5P
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
unii: U3RSY48JW5
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
unii: U3RSY48JW5
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: B697894SGQ
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
rxcui: 238910
unii: U3RSY48JW5
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
unii: U3RSY48JW5
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
unii: U3RSY48JW5
Medi-first Protective Coating BandageBENZETHONIUM CHLORIDE AND BENZOCAINEUnifirst First Aid Corporation05b0aef9-1553-4e95-8798-f41e5999bb462025-09-08WarningsExact identifier
unii: U3RSY48JW5
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
unii: U3RSY48JW5
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
AeroWipeSTING RELIEF PADAero Healthcare US LLC3d851c98-c9b9-f084-e063-6294a90acde22025-08-29WarningsExact identifier
unii: U3RSY48JW5
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLArmy & Air Force Exchange Service3d70450f-04ea-1885-e063-6294a90a05bd2025-08-28WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
application number: M022
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
application number: M022

Reported adverse events (FAERS/openFDA)#

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