Quality Choice Tolnaftate Antifungal

Product NDC: 63868-104
11-digit product format: 638680104
Labeler code: 63868
Product ID: 63868-104_602ee07d-770e-4328-e053-2991aa0ad96b
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Chain Drug Marketing Association Inc
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-05-31
Marketing end: 0000-00-00
Substance: TOLNAFTATE
Active strength: 1 g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	63868-104		I	Inactivated by FDA		2026-10-05
excluded package	package	63868-104	63868-104-46	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-104-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-104-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-104-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-104-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-104-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-104-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-104-46	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-104-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-104-46	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-104-46	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-104-46	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-104-46	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63868-104-46	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63868-104-46	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63868-104-46	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63868-104-46	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63868-104-46	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63868-104-46	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-104-46	2022-01-28	C162847	48780-1	d6a99b39-d02d-a426-e053-dadaa90af4c2	QC Anti-Fungal Cream 1oz NBE Tinactin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-104-46	Quality Choice Tolnaftate Antifungal	1 in 1 CARTON	CREAM	1		5
63868-104-46	Quality Choice Tolnaftate Antifungal	30 g in 1 TUBE	CREAM	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-104-46	GM - Gram	63868-104	364f5a3c-656d-44ea-ad4e-a31ae8504374	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-104	QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]	5	Legacy NDC, 2 package rows	20171213_684e9447-e16e-42e2-b268-e37b48eb2e92.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	684e9447-e16e-42e2-b268-e37b48eb2e92	5
103951	tolnaftate 10 MG/ML Topical Cream	SCD	684e9447-e16e-42e2-b268-e37b48eb2e92	5
103951	tolnaftate 1 % Topical Cream	SY	684e9447-e16e-42e2-b268-e37b48eb2e92	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-104-46	63868010446	1 TUBE in 1 CARTON (63868-104-46) > 30 g in 1 TUBE	1 tube	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QC Anti-Fungal Cream 1oz NBE Tinactin	Chain Drug Marketing Association Inc	2017-12-12	HUMAN OTC DRUG LABEL	5