FDA.reportPublic FDA data

Topcare

Product NDC
36800-443
11-digit product format
368000443
Labeler code
36800
Product ID
36800-443_5d30e185-1cc3-2777-e063-6394a90a7577
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Topco Associates LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-01
Substance
BENZOCAINE
Active strength
20 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308657Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6586fcda-b232-46b4-8461-c0042a4127c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-443-58TopcareMaximum Strength14.17 g in 1 BOTTLE, WITH APPLICATORLIQUID14.1714
36800-443-58TopcareMaximum Strength1 in 1 BLISTER PACKLIQUID114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-443TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO ASSOCIATES LLC]13Current NDC, Legacy NDC, 2 package rows20250119_6586fcda-b232-46b4-8461-c0042a4127c6.zip

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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN6586fcda-b232-46b4-8461-c0042a4127c614
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD6586fcda-b232-46b4-8461-c0042a4127c614
308657benzocaine 20 % Mucous Membrane Topical SolutionSY6586fcda-b232-46b4-8461-c0042a4127c614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-443-48368000443481 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-48) > 14.17 g in 1 BOTTLE, WITH APPLICATOR2014-10-010000-00-00NoNoCurrent
36800-443-58368000443581 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATOR2014-10-01NoNoCurrent