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 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	0192ccf9-1715-4e23-a6bf-8bd838cd8b0d	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	edcb8451-6fa7-4bc2-95f6-2a0806f7f3da	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	576660ed-203a-4842-9d39-c5be10daf976	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	1796b3ec-833a-4cf1-ba50-bc4da827f84f	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f5f9b-4192-15e6-e053-2995a90a6457	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	2b494372-de59-e462-e063-6294a90a08da	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	a225d515-430d-4e34-846c-0bfec3e74109	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	372f99c9-4ad3-4631-b8c8-2a34c47343cc	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	e554b5b2-cf91-464a-a930-3e1087f12c8d	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	98da331c-76c2-49fe-b687-6bfba4ae2e75	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d2195efa-597d-4ba9-a9b0-8df0d8f49311	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	fba82d55-94db-4432-b532-603fe57202be	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	9ed0fe31-e5f2-4d6d-8686-1286c6659847	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d5f42c30-343c-4e1d-950c-89bbd361fd27	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	7dce407f-bbe4-4a27-97ff-be33fd447461	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f28f3-a908-47a9-e053-2995a90a6cbd	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	a80cfd29-8314-4639-a811-afd5fdb630b0	2025-01-09	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