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 13 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Vicks Formula 44 Cough DropsMENTHOLThe Procter & Gamble Manufacturing Companybb9e483e-095d-8a42-e053-2a95a90ad8d62025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact 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