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
Ingredient	Strength
BENZOCAINE	7.5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1110816	Internal RxNorm lookup
1110820	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
28c5a993-fb5f-4091-af15-32ccae4b9a7d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58593-782-02	2020-02-19	C162847	48780-1	9d75b9d0-1cd2-f424-e053-dadaa90a57ce	28c5a993-fb5f-4091-af15-32ccae4b9a7d
58593-782-02	2020-01-31	C162847	48780-1	9d75b9d0-1cd2-f424-e053-dadaa90a57ce	28c5a993-fb5f-4091-af15-32ccae4b9a7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-782-02	FinaftaMultiOral	59 mL in 1 BOTTLE, SPRAY	SPRAY	59		12
58593-782-02	FinaftaMultiOral	1 in 1 CARTON	SPRAY	1		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FINAFTA MULTIORAL (BENZOCAINE) LIQUID [EFFICIENT LABORATORIES INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-782	FINAFTA MULTIORAL (BENZOCAINE) SPRAY [EFFICIENT LABORATORIES INC.]	12	Current NDC, Legacy NDC, 2 package rows	20241016_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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Bubble Gum Flavor For Kids 25g 50g	BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	354c1eda-ec5b-a8c7-e063-6294a90a871d	2025-05-16	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Clear Mint	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	444f931d-5e38-4cda-97ba-98aa0b5fe4f6	2025-05-08	Warnings	Exact identifier application number: M022
Listerine Clinical Solutions Gum Health Icy Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	06e1122b-1100-43c0-e063-6394a90a2e78	2025-04-22	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	5260258a-bb1e-43d6-bce1-70a38778a64a	2025-04-14	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	TARGET Corporation	93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65	2025-04-14	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee467ec4-bd5e-644a-e053-2a95a90ac273	2025-04-10	Warnings	Exact identifier application number: M022
Mouthwash	MENTHOL, METHYL SALICYLATE, THYMOL	Orazen Inc	873c43df-1d46-359b-e053-2a91aa0a4319	2025-04-07	Warnings	Exact identifier application number: M022
Sensodyne Complete Protection Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	e3cc3146-8aed-4f6b-a252-e379418c2b8d	2025-03-26	Warnings	Exact identifier application number: M022
Listerine Freshburst Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee1e1df9-74c6-d24b-e053-2a95a90a43d3	2025-03-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	edb9e374-4dba-5823-e053-2a95a90a3da5	2025-03-03	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Good Sense (Geiss, Destin & Dunn, Inc.)	cfe9be26-e4a4-413c-a602-2f5948e3bb7a	2025-03-03	Warnings	Exact identifier application number: M022
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier application number: M022
WHITE GLO CHARCOAL SENSITIVE	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	a5edb7fd-c637-5447-e053-2995a90a5a6f	2025-02-26	Warnings	Exact identifier application number: M022
Glorysmile Toothpaste.	GLORYSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	2ef48156-904d-e42a-e063-6394a90a3cd0	2025-02-25	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Walgreens	c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa	2025-02-21	Warnings	Exact identifier application number: M022
Sheffield Pain Relief	BENZOCAINE	Sheffield Pharmaceuticals LLC	e21abfdd-373d-42af-9535-fe1571382a65	2025-02-19	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Whole Foods Market	a2bb142e-8cbe-481e-bf4f-810ca6d14591	2025-02-12	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1110816	benzocaine 7.5 % Mucosal Spray	PSN	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12
1110820	Finafta Multi Oral 7.5 % Mucosal Spray	PSN	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12
1110820	benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]	SBD	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12
1110816	benzocaine 75 MG/ML Mucosal Spray	SCD	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12
1110820	Finafta Multi Oral 7.5 % Mucosal Spray	SY	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12
1110820	Finafta Multi Oral 75 MG/ML Mucosal Spray	SY	28c5a993-fb5f-4091-af15-32ccae4b9a7d	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-782-02	58593078202	1 BOTTLE, SPRAY in 1 CARTON (58593-782-02) / 59 mL in 1 BOTTLE, SPRAY	2004-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finafta MultiOral - Efficient Laboratories Inc.	Efficient Laboratories Inc.	2024-10-14	HUMAN OTC DRUG LABEL	12