FDA.reportPublic FDA data

Anbesol

Product NDC
80070-230
11-digit product format
800700230
Labeler code
80070
Product ID
80070-230_54dcc1e5-3718-75e8-e063-6294a90ab793
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Foundation Consumer Brands
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-15
Substance
BENZOCAINE
Active strength
200 mg/mL
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
Anbesol
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/mL

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
308657Internal RxNorm lookup
608897Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c6ac499-9bd2-4ea5-9f26-df7947bff4a6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-230-41AnbesolMaximum Strength12 mL in 1 BOTTLESOLUTION124
80070-230-41AnbesolMaximum Strength1 in 1 BLISTER PACKSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80070-230ANBESOL MAXIMUM STRENGTH (BENZOCAINE) SOLUTION [FOUNDATION CONSUMER BRANDS]4Current NDC, Legacy NDC, 2 package rows20250221_8c6ac499-9bd2-4ea5-9f26-df7947bff4a6.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
608897Anbesol 20 % Mucous Membrane Topical SolutionPSN8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
608897benzocaine 200 MG/ML Mucous Membrane Topical Solution [Anbesol]SBD8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
608897Anbesol 20 % Mucous Membrane Topical SolutionSY8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
608897Anbesol 200 MG/ML Mucous Membrane Topical SolutionSY8c6ac499-9bd2-4ea5-9f26-df7947bff4a64
308657benzocaine 20 % Mucous Membrane Topical SolutionSY8c6ac499-9bd2-4ea5-9f26-df7947bff4a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80070-230-41800700230411 BOTTLE in 1 BLISTER PACK (80070-230-41) / 12 mL in 1 BOTTLE1 bottle2021-09-150000-00-00NoNoCurrent