FDA.reportPublic FDA data

Finafta

Product NDC
65852-001
11-digit product format
658520001
Labeler code
65852
Product ID
65852-001_3f7c6100-fd2d-9cd9-e063-6294a90a2486
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SPRAY
Route
ORAL
Labeler
Dextrum Laboratories Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-09-01
Substance
BENZOCAINE
Active strength
7.5 mg/100mL
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
Finafta
Brand name suffix
MultiOral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE7.5 mg/100mL

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
1110816Internal RxNorm lookup
1110820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb027ab8-4175-4cc0-a73e-991dfb113df9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-001-02FinaftaMultiOral1 in 1 CARTONSPRAY11
65852-001-02FinaftaMultiOral59 mL in 1 BOTTLE, SPRAYSPRAY591

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
1110816benzocaine 7.5 % Mucosal SprayPSNcb027ab8-4175-4cc0-a73e-991dfb113df91
1110820Finafta Multi Oral 7.5 % Mucosal SprayPSNcb027ab8-4175-4cc0-a73e-991dfb113df91
1110820benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]SBDcb027ab8-4175-4cc0-a73e-991dfb113df91
1110816benzocaine 75 MG/ML Mucosal SpraySCDcb027ab8-4175-4cc0-a73e-991dfb113df91
1110820Finafta Multi Oral 7.5 % Mucosal SpraySYcb027ab8-4175-4cc0-a73e-991dfb113df91
1110820Finafta Multi Oral 75 MG/ML Mucosal SpraySYcb027ab8-4175-4cc0-a73e-991dfb113df91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-001-02658520001021 BOTTLE, SPRAY in 1 CARTON (65852-001-02) / 59 mL in 1 BOTTLE, SPRAY2004-09-01NoNoCurrent