Topicale

Product NDC: 10733-173
11-digit product format: 107330173
Labeler code: 10733
Product ID: 10733-173_29694bac-976b-0291-e063-6394a90a32d1
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: PATCH
Route: ORAL
Labeler: Medical Products Laboratories, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-06
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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8282a4a6-b77c-75fc-e053-2991aa0ad4ac	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10733-173-01	Topicale	5 g in 1 CARTON	PATCH	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10733-173	TOPICALE (BENZOCAINE) PATCH [MEDICAL PRODUCTS LABORATORIES, INC.]	4	Current NDC, 1 package rows	20241218_8282a4a6-b77c-75fc-e053-2991aa0ad4ac.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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Gel Oral Pain Relief	BENZOCAINE BENZALKONIUM CHLORIDE	Savvy Care and Cosmetics	05ede7e4-5a0a-c942-e063-6294a90a8a24	2024-12-19	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon	SODIUM BICARBONATE	Lotus Brands, Inc.	6703b29d-cdc9-4c74-91c0-fb0c98dd043e	2024-12-18	Warnings	Exact identifier application number: M022
Red Cross Oral Pain Relief	BENZOCAINE	The Mentholatum Company	cbd41429-f730-4577-9f06-ef1831cf62e1	2024-12-17	Warnings	Exact identifier application number: M022
Red Cross Canker Sore	BENZOCAINE	The Mentholatum Company	54cfff96-6665-4b36-a15d-10bf6cf3a1f9	2024-12-17	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	116956644	2981217f-f250-c090-e063-6294a90a85b0	2024-12-17	Warnings	Exact identifier application number: M022
Kank-A Mouth Pain	BENZOCAINE	Blistex Inc.	eebc03ba-f849-4e70-a653-834f383b6aa4	2024-12-17	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8282a4a6-b77c-75fc-e053-2991aa0ad4ac	2024-12-16	Warnings	Exact identifier application number: M022 ndc (product): 10733-173
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	9452bff4-8c08-eff9-e053-2a95a90a67ed	2024-12-16	Warnings	Exact identifier application number: M022
PHENOL	PHENOL	CHAIN DRUG MARKETING ASSOCIATION INC.	2379e23a-72fe-4e94-9d7e-9b623c0db174	2024-12-13	Warnings	Exact identifier application number: M022
KANKA SoftBrush	BENZOCAINE AND ZINC CHLORIDE	Blistex Inc	093f3545-1d8e-48a3-a533-e9c3ae6d740b	2024-12-12	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	826eaef8-4457-3dc2-e053-2991aa0a528b	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8281700c-10f9-841c-e053-2991aa0a918f	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	82824416-80de-76bd-e053-2a91aa0ad8b5	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	e3da0e63-a891-72bd-e053-2a95a90a58bc	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories, Inc.	e3d924b5-0788-46d3-e053-2995a90a027b	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	fa433031-7376-0e5b-e053-6394a90a5f75	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	eedf13dc-a009-027a-e053-2995a90a8ec8	2024-12-11	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola USA Inc.	763e8234-60be-4b1f-9f78-01c574f35d0a	2024-12-10	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola USA Inc.	989f8509-cd28-48e7-9aa1-baddfbcac95a	2024-12-10	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10733-173-01	10733017301	5 g in 1 CARTON (10733-173-01)	5 g	2019-05-06	No	No	Current