TopCare

Product NDC: 36800-600
11-digit product format: 368000600
Labeler code: 36800
Product ID: 36800-600_433ad935-b453-0d24-e063-6394a90ab04f
Type: HUMAN OTC DRUG
Nonproprietary name: Phenol
Dosage form: SPRAY
Route: ORAL
Labeler: TOPCO ASSOCIATES, LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-05
Substance: PHENOL
Active strength: 1.4 g/100mL
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: TopCare
Brand name suffix: Cherry Flavor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOL	1.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
339NCG44TV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198776	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
5d3f0610-deb4-4180-ae19-2c65ed2f368b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-600-06	TopCareCherry Flavor	177 mL in 1 BOTTLE, SPRAY	SPRAY	177		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-600	TOPCARE CHERRY FLAVOR (PHENOL) SPRAY [TOPCO ASSOCIATES, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20241107_5d3f0610-deb4-4180-ae19-2c65ed2f368b.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
339NCG44TV	PHENOL	108-95-2	PHENOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198776	phenol 1.4 % Mucosal Spray	PSN	5d3f0610-deb4-4180-ae19-2c65ed2f368b	7
198776	phenol 14 MG/ML Mucosal Spray	SCD	5d3f0610-deb4-4180-ae19-2c65ed2f368b	7
198776	phenol 1.4 % Mucosal Spray	SY	5d3f0610-deb4-4180-ae19-2c65ed2f368b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-600-06	36800060006	177 mL in 1 BOTTLE, SPRAY (36800-600-06)	177 ml	2019-03-05	0000-00-00	No	No	Current