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 35 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel Antiseptic Alcohol-Free Mouth Sore Rinse	HYDROGEN PEROXIDE, MENTHOL	Church & Dwight Co., Inc.	99d47d6a-fa2e-d5ee-e053-2995a90aa11d	2024-11-27	Warnings	Exact identifier application number: M022
Orajel 2x Gum Pain Alcohol-Free	MENTHOL AND HYDROGEN PEROXIDE	Church & Dwight Co., Inc.	adf37010-922c-4441-93d6-1e1a95025e90	2024-11-27	Warnings	Exact identifier application number: M022
Maximum Strength Cold Sore Treatment	CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM	Meijer Distribution Inc	9220772c-b3b7-4855-e053-2a95a90a94f6	2024-11-27	Warnings	Exact identifier application number: M022
Peroxyl Mouth Sore Mild Mint	HYDROGEN PEROXIDE	Colgate Oral Pharmaceuticals Inc.	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	2024-11-25	Warnings	Exact identifier application number: M022
NICE SORE THROAT Spearmint	PHENOL	Leosons Overseas Corp	5fc68f04-ec15-11c0-e053-2a91aa0a1952	2024-11-20	Warnings	Exact identifier application number: M022
Sore Throat Relief	PHENOL	WinCo Foods, LLC	0f4dae93-2e42-4815-be2f-ff4887a8fd5f	2024-11-20	Warnings	Exact identifier application number: M022
TANAC Oral Pain Reliever	BENZOCAINE	Leosons Overseas Corp	81cc61fa-31a7-2214-e053-2a91aa0ae46a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Honey Lemon	PHENOL	Leosons Overseas Corp	601aea98-e6ab-de6f-e053-2a91aa0a824a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Cherry	PHENOL	Leosons Overseas Corp	5f21694c-d1c9-0e64-e053-2a91aa0a0ff0	2024-11-15	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL	Safeway, Inc.	f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d	2024-11-14	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry	PHENOL	Best Choice (Valu Merchandisers Company)	c0a47d59-3e15-453d-97a7-d626e8650862	2024-11-14	Warnings	Exact identifier application number: M022
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

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