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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	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