FDA.reportPublic FDA data

Topicale

Product NDC
10733-167
11-digit product format
107330167
Labeler code
10733
Product ID
10733-167_28dd17ff-9097-d336-e063-6394a90a00fd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
Medical Products Laboratories, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-05
Substance
BENZOCAINE
Active strength
180 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

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
Topicale
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE180 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1042838Internal RxNorm lookup
1049213Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8281700c-10f9-841c-e053-2991aa0a918fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-167-43Topicale43 g in 1 BOTTLE, PUMPGEL433

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10733-167-43GM - Gram10733-1677a8f812c-78dd-4d13-992d-402c63fed35e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-167TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.]3Current NDC, 1 package rows20241213_8281700c-10f9-841c-e053-2991aa0a918f.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 19 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks VapoCool Sore ThroatBENZOCAINE AND MENTHOLThe Procter & Gamble Manufacturing Companybefe6da7-1ccb-6ae4-e053-2a95a90ae4cf2025-10-02WarningsExact identifier
application number: M022
Vicks VapoCOOL Severe WINTERFROSTMENTHOLThe Procter & Gamble Manufacturing Company06579fc7-7d91-2a7b-e063-6394a90ae5162025-10-01WarningsExact identifier
application number: M022
Mouth Sore Relief Professional StrengthBENZOCAINECVS Pharmacy1b7209f6-8368-47fa-8df2-b049613b8c1b2025-09-30WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEFamily Dollar (FAMILY WELLNESS)9db73da2-5b70-41e6-bcf9-caa7f11420242025-09-29WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic LiquidCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47d7e1-b6ae-efd1-e063-6394a90a46022025-09-27WarningsExact identifier
application number: M022
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEDextrum Laboratories Inc.cb027ab8-4175-4cc0-a73e-991dfb113df92025-09-23WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
application number: M022
Dental ReliefBENZOCAINECintas Corporation0f40f775-797e-43cf-88c9-00eea666494f2025-09-23WarningsExact identifier
application number: M022
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
application number: M022
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf25-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf28-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f19a1a7-c234-8d26-e063-6394a90ad7e92025-09-18WarningsExact identifier
application number: M022
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
Vicks VapoCOOLMENTHOLThe Procter & Gamble Manufacturing Company3de4268b-61a0-b92f-e063-6394a90a40b92025-09-03WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1042838benzocaine 18 % Oral GelPSN8281700c-10f9-841c-e053-2991aa0a918f3
1049213Topicale 18 % Oral GelPSN8281700c-10f9-841c-e053-2991aa0a918f3
1049213benzocaine 0.18 MG/MG Oral Gel [Topicale]SBD8281700c-10f9-841c-e053-2991aa0a918f3
1042838benzocaine 0.18 MG/MG Oral GelSCD8281700c-10f9-841c-e053-2991aa0a918f3
1042838benzocaine 18 % Oral GelSY8281700c-10f9-841c-e053-2991aa0a918f3
1049213Topicale 0.18 MG/MG Oral GelSY8281700c-10f9-841c-e053-2991aa0a918f3
1049213Topicale 18 % Oral GelSY8281700c-10f9-841c-e053-2991aa0a918f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10733-167-431073301674343 g in 1 BOTTLE, PUMP (10733-167-43) 43 g2019-03-05NoNoCurrent