Finafta

Product NDC
58593-782
11-digit product format
585930782
Labeler code
58593
Product ID
58593-782_24702e3e-55f4-4231-e063-6394a90aebbe
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SPRAY
Route
ORAL
Labeler
Efficient 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
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
Finafta
Brand name suffix
MultiOral
Listing expiration
2027-12-31

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
28c5a993-fb5f-4091-af15-32ccae4b9a7dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-782-022020-02-19C16284748780-19d75b9d0-1cd2-f424-e053-dadaa90a57ce28c5a993-fb5f-4091-af15-32ccae4b9a7d
58593-782-022020-01-31C16284748780-19d75b9d0-1cd2-f424-e053-dadaa90a57ce28c5a993-fb5f-4091-af15-32ccae4b9a7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-782-02FinaftaMultiOral59 mL in 1 BOTTLE, SPRAYSPRAY5912
58593-782-02FinaftaMultiOral1 in 1 CARTONSPRAY112

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-782FINAFTA MULTIORAL (BENZOCAINE) SPRAY [EFFICIENT LABORATORIES INC.]12Current NDC, Legacy NDC, 2 package rows20241016_28c5a993-fb5f-4091-af15-32ccae4b9a7d.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 29 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BencoCaine Topical AnestheticBENZOCAINEBenco Dental3cc5d095-5f9c-4e4d-8971-0079e949b7ca2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89d23b14-398e-4b3e-955a-724ff66579b92025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentale381b2d5-6485-4d11-94f4-eec335d5cf412025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental8ffc4af6-d99c-4964-8d7d-4644bc699a3d2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a932-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a934-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9236161b-a427-6efa-e053-2a95a90a99c42025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9224ecb4-c58f-ae7d-e053-2995a90ac2ed2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923614c5-d1bf-b444-e053-2995a90aa5c62025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235cb3f-a45b-10e5-e053-2995a90ae5e32025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923636fb-8f9a-480b-e053-2995a90a618e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235fd71-3dd9-436a-e053-2995a90af7ec2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3fe5283f-967b-4f57-941b-ab80ea40ce502025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental4860dc44-6811-4db5-aeda-05fac830b1882025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental7619d53c-3f6e-4041-93a1-df33d5f9e3f72025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalb2cd6d74-b35a-4cc1-8752-519bce9047372025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentala948c5a7-d431-4f46-bb59-8974924e63202025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental18d2e370-b30e-4b50-85d8-265964be2dde2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3eb3bbc6-07d4-44c5-adac-701db06f9cd82025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalfcfcece3-ee81-4275-82e2-aba93a6862ee2025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110816benzocaine 7.5 % Mucosal SprayPSN28c5a993-fb5f-4091-af15-32ccae4b9a7d12
1110820Finafta Multi Oral 7.5 % Mucosal SprayPSN28c5a993-fb5f-4091-af15-32ccae4b9a7d12
1110820benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]SBD28c5a993-fb5f-4091-af15-32ccae4b9a7d12
1110816benzocaine 75 MG/ML Mucosal SpraySCD28c5a993-fb5f-4091-af15-32ccae4b9a7d12
1110820Finafta Multi Oral 7.5 % Mucosal SpraySY28c5a993-fb5f-4091-af15-32ccae4b9a7d12
1110820Finafta Multi Oral 75 MG/ML Mucosal SpraySY28c5a993-fb5f-4091-af15-32ccae4b9a7d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58593-782-02585930782021 BOTTLE, SPRAY in 1 CARTON (58593-782-02) / 59 mL in 1 BOTTLE, SPRAY2004-09-010000-00-00NoNoCurrent