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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	b30e4b32-89dd-4e53-81d5-1415105361d4	2024-10-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier application number: M022 ndc (product): 58593-782
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier application number: M022
Anadent Kanka Gel	BENZOCAINE	BELMORA LLC	e0f73d78-5db1-43b4-8f58-e5410ca4560f	2024-10-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Navajo Manufacturing Company Inc.	f5f26e2f-8a1f-4687-e053-2a95a90ae378	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Navajo Manufacturing Company Inc.	f89bf259-b738-8229-e053-6394a90a0c59	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Navajo Manufacturing Company Inc.	f71c53e0-e2dd-16f9-e053-6394a90accff	2024-10-03	Warnings	Exact identifier application number: M022
Crest Pro Health	CETYLPYRIDINIUM CHLORIDE	Navajo Manufacturing Company Inc.	65bf17a9-21ad-27cb-e053-2991aa0afc40	2024-10-02	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	94e07979-943b-45bb-8e2b-90d686f3692e	2024-09-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	6eb304dd-2a24-4fa0-9d39-71264e88dd16	2024-08-29	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cfda7efa-86fa-470d-a79f-81907e31778a	2024-08-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Kids Bubble Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	e403529a-0fac-4dab-b75c-46906add096b	2024-08-13	Warnings	Exact identifier application number: M022
Calcium Carbonate Assorted Flavors	ANTACID TABLETS	NuCare Pharmaceuticals,Inc.	af10dfb6-fef3-3410-e053-2995a90a9130	2024-07-17	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening Plus	POTASSIUM NITRATE	Haleon US Holdings LLC	f757ccdd-b316-4799-a34a-10edbb73da6b	2024-07-12	Warnings	Exact identifier application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE, SODIUM FLUORIDE	Lidl US, LLC	baef7f15-8082-4e61-8c08-8beda8ad40c0	2024-07-03	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