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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308657	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
6586fcda-b232-46b4-8461-c0042a4127c6	Available on FDA.report

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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	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