Topicale

Product NDC: 10733-167
11-digit product format: 107330167
Labeler code: 10733
Product ID: 10733-167_28dd17ff-9097-d336-e063-6394a90a00fd
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: ORAL
Labeler: Medical Products Laboratories, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-05
Substance: BENZOCAINE
Active strength: 180 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Topicale
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	180 mg/g

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
1042838	Internal RxNorm lookup
1049213	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
8281700c-10f9-841c-e053-2991aa0a918f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10733-167-43	Topicale	43 g in 1 BOTTLE, PUMP	GEL	43		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10733-167-43	GM - Gram	10733-167	7a8f812c-78dd-4d13-992d-402c63fed35e	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10733-167	TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.]	3	Current NDC, 1 package rows	20241213_8281700c-10f9-841c-e053-2991aa0a918f.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	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
1042838	benzocaine 18 % Oral Gel	PSN	8281700c-10f9-841c-e053-2991aa0a918f	3
1049213	Topicale 18 % Oral Gel	PSN	8281700c-10f9-841c-e053-2991aa0a918f	3
1049213	benzocaine 0.18 MG/MG Oral Gel [Topicale]	SBD	8281700c-10f9-841c-e053-2991aa0a918f	3
1042838	benzocaine 0.18 MG/MG Oral Gel	SCD	8281700c-10f9-841c-e053-2991aa0a918f	3
1042838	benzocaine 18 % Oral Gel	SY	8281700c-10f9-841c-e053-2991aa0a918f	3
1049213	Topicale 0.18 MG/MG Oral Gel	SY	8281700c-10f9-841c-e053-2991aa0a918f	3
1049213	Topicale 18 % Oral Gel	SY	8281700c-10f9-841c-e053-2991aa0a918f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10733-167-43	10733016743	43 g in 1 BOTTLE, PUMP (10733-167-43)	43 g	2019-03-05	No	No	Current