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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART SALINE	SALINE NASAL (SODIUM CHLORIDE)	WALMART STORES INC	06906744-49a5-4bab-8539-af2d235df9e8	2025-10-28	Warnings	Exact identifier application number: M022
Saline	NASAL	PUBLIX SUPER MARKETS, INC	19841567-9511-43d6-ba4e-d1e1bd3481a4	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Fast Relief Oral Anesthetic	PHENOL	PUBLIX SUPER MARKETS, INC	89291f12-bbc3-4472-8ad3-a34485af72c9	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Menthol Flavor	PHENOL	PUBLIX SUPER MARKETS, INC	9296c49e-557c-43ed-9527-fcba5093a8dc	2025-10-28	Warnings	Exact identifier application number: M022
WinCo Foods Maximum Strength Oral Analgesic	BENZOCAINE	WinCo Foods, LLC	c22a7726-8c3f-41bf-b852-8456b2be6f93	2025-10-28	Warnings	Exact identifier application number: M022
Rugby Cherry Flavor	PHENOL	RUGBY LABORATORIES	3d668c78-8130-45d4-bcb7-dddcb2fbe7a3	2025-10-25	Warnings	Exact identifier application number: M022
LolliCaine Bubble Gum	BENZOCAINE	Centrix, Inc.	56ae3a84-6bca-4906-a03d-9d755e1fba3b	2025-10-24	Warnings	Exact identifier application number: M022
Diabetic Tussin Sore Throat Cherry	PHENOL	MEDTECH PRODUCTS INC	ab351229-5771-4c6c-92a8-721cc41c002f	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar Free	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	34e4234c-ed61-4795-99fe-d281cdb0af88	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	6b1a50d0-be54-4fcb-b5e2-b47abf3555c0	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Childrens Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	38ff6922-1abe-4fa9-a74e-ede604f707b5	2025-10-23	Warnings	Exact identifier application number: M022
Boka Sensitive	POTASSIUM NITRATE	Karaka LLC	40be9fab-53db-c67a-e063-6394a90a48cb	2025-10-23	Warnings	Exact identifier application number: M022
Canker Care Plus	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	1ec960db-52d5-4d99-a7f7-a2e538d28724	2025-10-20	Warnings	Exact identifier application number: M022
meijer Sensitive EXTRA WHITENING	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	bbcffb88-0bd4-4883-bb83-0b7a1428ad12	2025-10-20	Warnings	Exact identifier application number: M022
Quality Choice Maximum Strength Oral Pain Relieving	BENZOCAINE	Chain Drug Marketing Association Inc	dbde8e7f-85d8-4083-b01a-3a7e410a7747	2025-10-17	Warnings	Exact identifier application number: M022
Quality Choice	BENZOCAINE	Chain Drug Marketing Association, Inc.	24c3c4a3-bd76-198d-e063-6394a90ad45a	2025-10-16	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Cardinal Health	b84203bd-23e9-427d-83d8-f4c88266e23c	2025-10-14	Warnings	Exact identifier application number: M022
Finafta	BENZOCAINE, GLYCERIN	Efficient Laboratories Inc.	03368603-3e11-c2fa-e063-6294a90a04ea	2025-10-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening Action	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	e8a62f24-1db6-45fb-b6e1-5e57103f82bc	2025-10-14	Warnings	Exact identifier application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT	POTASSIUM NITRATE, SODIUM FLUORIDE	Ashtel Studios, Inc.	bc74d2a6-fe34-44cf-b015-70ed4d47c933	2025-10-13	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