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

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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact 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