FDA.reportPublic FDA data

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]2

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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact 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