Tolnaftate

Product NDC: 0904-0722
Requested package NDC: 0904-0722-36
11-digit product format: 009040722
Labeler code: 0904
Product ID: 0904-0722_d4c0d927-7a7a-4b89-ba8e-5f05659586bf
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-02-11
Marketing end: 0000-00-00
Substance: TOLNAFTATE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-0722	0904-0722-36	D	Discontinued by firm		2026-08-11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-0722-36	2021-12-01	C162847	48780-1	ba0f9c33-54b6-a910-e053-dadaa90a0b85	5a05dc53-f817-40bd-9355-a3266afb1179
0904-0722-36	2021-01-29	C162847	48780-1	ba0f9c33-54b6-a910-e053-dadaa90a0b85	5a05dc53-f817-40bd-9355-a3266afb1179

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0722-36	GM - Gram	0904-0722	26b64571-2bd2-4d74-afdc-5eae458205bb	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-0722	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	4	Legacy NDC	20241114_5a05dc53-f817-40bd-9355-a3266afb1179.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	63665de7-8415-651f-e053-2991aa0ac2bb	4
103951	tolnaftate 10 MG/ML Topical Cream	SCD	63665de7-8415-651f-e053-2991aa0ac2bb	4
103951	tolnaftate 1 % Topical Cream	SY	63665de7-8415-651f-e053-2991aa0ac2bb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-0722-36	00904072236	1 TUBE in 1 CARTON (0904-0722-36) > 14.18 g in 1 TUBE	1 tube	2010-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolnaftate - Major Pharmaceuticals	Major Pharmaceuticals	2024-11-12	HUMAN OTC DRUG LABEL	4
Tolnaftate - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-06	HUMAN OTC DRUG LABEL	4
Tolnaftate - A-S Medication Solutions	A-S Medication Solutions	2023-03-02	HUMAN OTC DRUG LABEL	18