FDA.reportPublic FDA data

Alpha-Caine

Product NDC
55346-2901
11-digit product format
553462901
Labeler code
55346
Product ID
55346-2901_42c88f44-2eda-edae-e063-6294a90a51d4
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL; PERIODONTAL
Labeler
Dental Technologies, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1999-12-31
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alpha-Caine
Brand name suffix
Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 1297832

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-2901-1Alpha-CaineTopical Anesthetic30 g in 1 BOTTLE, PLASTICGEL308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4
BenzocaineACTIVE MOIETYU3RSY48JW5ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-2901ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]7Current NDC, Legacy NDC, 1 package rows20231216_719743f9-21fc-4568-b879-acdfa4639464.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297832ALPHA-CAINE 20 % Oral GelPSN719743f9-21fc-4568-b879-acdfa46394648
238910benzocaine 20 % Oral GelPSN719743f9-21fc-4568-b879-acdfa46394648
1297832benzocaine 0.2 MG/MG Oral Gel [Alpha-caine]SBD719743f9-21fc-4568-b879-acdfa46394648
238910benzocaine 0.2 MG/MG Oral GelSCD719743f9-21fc-4568-b879-acdfa46394648
1297832Alpha-caine 0.2 MG/MG Oral GelSY719743f9-21fc-4568-b879-acdfa46394648
1297832Alpha-caine 20 % Oral GelSY719743f9-21fc-4568-b879-acdfa46394648
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY719743f9-21fc-4568-b879-acdfa46394648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55346-2901-15534629010130 g in 1 BOTTLE, PLASTIC (55346-2901-1) 30 g1999-12-310000-00-00NoNoCurrent