TopCare

Product NDC: 36800-052
11-digit product format: 368000052
Labeler code: 36800
Product ID: 36800-052_cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04
Type: HUMAN OTC DRUG
Nonproprietary name: Tolnaftate
Dosage form: CREAM
Route: TOPICAL
Labeler: Topco Associates LLC
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2006-02-17
Marketing end: 0000-00-00
Substance: TOLNAFTATE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-052		I	Inactivated by FDA		2026-10-05
excluded package	package	36800-052	36800-052-60	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-052-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-052-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-052-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-052-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-052-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-052-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-052-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-052-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-052-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-052-60	2025-01-30	C162847	48780-1	2cef2736-b285-d83d-e063-dadaa90ab31f	TopCare ® Tolnaftate Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-052-60	TopCare Tolnaftate Antifungal	1 in 1 CARTON	CREAM	1		4
36800-052-60	TopCare Tolnaftate Antifungal	14.2 g in 1 TUBE	CREAM	14.2		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tolnaftate	ACTIVE INGREDIENT	06KB629TKV	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
Tolnaftate	ACTIVE MOIETY	06KB629TKV	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
Polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-052	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	4	Legacy NDC, 2 package rows	20201203_aba4ce9a-ae88-4223-b20f-d7897f7c2232.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103951	tolnaftate 1 % Topical Cream	PSN	aba4ce9a-ae88-4223-b20f-d7897f7c2232	4
103951	tolnaftate 10 MG/ML Topical Cream	SCD	aba4ce9a-ae88-4223-b20f-d7897f7c2232	4
103951	tolnaftate 1 % Topical Cream	SY	aba4ce9a-ae88-4223-b20f-d7897f7c2232	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-052-60	36800005260	1 TUBE in 1 CARTON (36800-052-60) > 14.2 g in 1 TUBE	1 tube	2006-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare ® Tolnaftate Antifungal Cream	Topco Associates LLC \| Natureplex LLC	2020-12-02	HUMAN OTC DRUG LABEL	4