Topcare

Product NDC: 36800-443
11-digit product format: 368000443
Labeler code: 36800
Product ID: 36800-443_5d30e185-1cc3-2777-e063-6394a90a7577
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: LIQUID
Route: ORAL
Labeler: Topco Associates LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-01
Substance: BENZOCAINE
Active strength: 20 g/100g
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: Topcare
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-443-58	TopcareMaximum Strength	14.17 g in 1 BOTTLE, WITH APPLICATOR	LIQUID	14.17		14
36800-443-58	TopcareMaximum Strength	1 in 1 BLISTER PACK	LIQUID	1		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-443	TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO ASSOCIATES LLC]	13	Current NDC, Legacy NDC, 2 package rows	20250119_6586fcda-b232-46b4-8461-c0042a4127c6.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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GuruNanda Oxyfusion	HYDROGEN PEROXIDE	GURUNANDA, LLC	3be317b9-a5d8-b198-e063-6394a90af985	2025-11-11	Warnings	Exact identifier application number: M022
GuruNanda Oral Pain Relief	MENTHOL	GURUNANDA, LLC	3b8f3562-0e46-bea4-e063-6294a90adb71	2025-11-11	Warnings	Exact identifier application number: M022
TopCare Cherry Flavor	PHENOL	TOPCO ASSOCIATES, LLC	5d3f0610-deb4-4180-ae19-2c65ed2f368b	2025-11-10	Warnings	Exact identifier application number: M022
Topcare Sore Throat Menthol Flavor	PHENOL	TOPCO ASSOCIATES LLC	fb1f2c11-2508-4985-bae5-7d547bd6aa23	2025-11-10	Warnings	Exact identifier application number: M022
Zilactin-B	BENZOCAINE	ASCENT CONSUMER PRODUCTS, INC	42eeb3d4-bac6-4e29-e063-6294a90a644d	2025-11-06	Warnings	Exact identifier application number: M022
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	106b6115-d043-4050-80c6-1d82456dea02	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	4c278122-2643-46bf-9e44-11985210a16e	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fee9969d-ad1a-4f44-9741-a0a44c9e1128	2025-11-06	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	Target Corporation	0ddf9945-147d-4b25-98a6-4e9f12a4656f	2025-11-05	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	e6a312e5-17ac-46f0-8723-4e40eeecd69f	2025-11-04	Warnings	Exact identifier application number: M022
PEROXY SHIELD MOUTH SORE	1.5% HYDROGEN PEROXIDE	Dental Technologies, Inc.	a72e433b-1b7d-4a0c-e053-2995a90a30c4	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ae628766-25b7-4b4f-abb8-a43faf2f44b9	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	719743f9-21fc-4568-b879-acdfa4639464	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ff0695a1-1d7d-4b51-97fd-689e56d914fe	2025-11-04	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f7edf75c-cdba-4dde-bfc5-a04af34759d3	2025-11-03	Warnings	Exact identifier application number: M022
7 Select Oral Pain Maximum Strength Relief	BENZOCAINE	7-ELEVEN, INC.	f170a570-1c50-4b9a-be16-9b01bf5eaa74	2025-10-31	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE AND BENZALKONIUM CHLORIDE	Universal Distribution Center LLC	18520f9b-4d35-1e9c-e063-6294a90aaa39	2025-10-30	Warnings	Exact identifier application number: M022
Iodent Oral Analgesic	BENZOCAINE	United Exchange Corp.	63902125-f8dc-0ada-e053-2991aa0a7ce5	2025-10-30	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	BETTER LIVING BRANDS, LLC	3bded237-4d2c-4b38-bedc-267fdc374194	2025-10-29	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
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	6586fcda-b232-46b4-8461-c0042a4127c6	14
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	6586fcda-b232-46b4-8461-c0042a4127c6	14
308657	benzocaine 20 % Mucous Membrane Topical Solution	SY	6586fcda-b232-46b4-8461-c0042a4127c6	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-443-48	36800044348	1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-48) > 14.17 g in 1 BOTTLE, WITH APPLICATOR	2014-10-01	0000-00-00	No	No	Current
36800-443-58	36800044358	1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATOR	2014-10-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820344 Top Care Oral Pain Relief Liquid	Topco Associates LLC \| Lornamead Products \| HK KOLMAR CANADA, INC	2026-10-06	HUMAN OTC DRUG LABEL	15