Tolnaftate Cream 1% ANTIFUNGAL

Product NDC: 69396-016
Requested package NDC: 69396-016-33
11-digit product format: 693960016
Labeler code: 69396
Product ID: 69396-016_352f8de3-8ff3-4098-e063-6294a90ace4d
Type: HUMAN OTC DRUG
Nonproprietary name: Tolnaftate
Dosage form: CREAM
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals Usa Llc
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-04-09
Substance: TOLNAFTATE
Active strength: 1 g/100g
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: Tolnaftate Cream 1% ANTIFUNGAL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
06KB629TKV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103951	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
96a40ccd-17f7-4e4e-98da-207802fa2b2d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69396-016-05	Tolnaftate Cream 1% ANTIFUNGAL	1 in 1 BOX	CREAM	1	8
69396-016-05	Tolnaftate Cream 1% ANTIFUNGAL	15 g in 1 TUBE	CREAM	15	8
69396-016-20	Tolnaftate Cream 1% ANTIFUNGAL	1 in 1 BOX	CREAM	1	8
69396-016-20	Tolnaftate Cream 1% ANTIFUNGAL	30 g in 1 TUBE	CREAM	30	8
69396-016-33	Tolnaftate Cream 1% ANTIFUNGAL	30 g in 1 TUBE	CREAM	30	8
69396-016-33	Tolnaftate Cream 1% ANTIFUNGAL	3 in 1 BOX	CREAM	3	8
69396-016-66	Tolnaftate Cream 1% ANTIFUNGAL	30 g in 1 TUBE	CREAM	30	8
69396-016-66	Tolnaftate Cream 1% ANTIFUNGAL	6 in 1 BOX	CREAM	6	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-016-20	GM - Gram	69396-016	aa3c307b-f4ba-43f9-a916-a7f90c077987	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-016	TOLNAFTATE CREAM 1% ANTIFUNGAL (TOLNAFTATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	8	Current NDC, Legacy NDC, 8 package rows	20250516_96a40ccd-17f7-4e4e-98da-207802fa2b2d.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 49 · 967 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OetMoe Antifungal Solution	OETMOE ANTIFUNGAL SOLUTION	Shenzhen Earth Surface Trading Co., Ltd.	3c26d917-4186-6f02-e063-6394a90a99f6	2025-08-12	Warnings	Exact identifier application number: M005
Cureforte Anti Fungal Foot Care	ANTI FUNGAL FOOT CARE DROPS	STEEL CITY HEALTH PRIVATE LIMITED	39f762a6-9d0c-8ded-e063-6394a90a3659	2025-08-11	Warnings	Exact identifier application number: M005
Derman Antifungal Powder Tolnaftate	TOLNAFTATE	Taisho Pharmaceutical California Inc.	3a854765-740c-4719-8abf-4b3f932cdee0	2025-08-07	Warnings	Exact identifier application number: M005
Derman antifungal cream	TOLNAFTATE	Taisho Pharmaceutical California Inc.	15d9b3c9-01af-4083-a1bc-014505d8798d	2025-08-07	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Hudson Health LLC	24b22794-f9f8-6f32-e063-6394a90aec98	2025-08-07	Warnings	Exact identifier application number: M005
Toe Area Treatment	TOLNAFTATE	CVS	17681cc8-fbb1-a0cf-e063-6294a90add18	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	178e7b3f-949f-3f51-e063-6294a90a9395	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	LEADER/Cardinal Health 110, Inc.	17695563-3765-74cb-e063-6294a90a6120	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Target Corporation	1dff278f-47bc-459a-e063-6394a90a2646	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	TopCo Associates	19c268a1-7b2e-63c9-e063-6394a90acddc	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid Maximum Strength	TOLNAFTATE	Walgreens Company	137eabb7-cb4f-1631-e063-6294a90ab847	2025-08-07	Warnings	Exact identifier application number: M005
WCTNGO Fungal Nail Treatment Swabs	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3bad0d73-b33d-b962-e063-6294a90a7ba7	2025-08-06	Warnings	Exact identifier application number: M005
ONIADBA Nail Fungus Treatment Pen	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3bad19f1-d5b3-c5de-e063-6294a90a0c03	2025-08-06	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Premier Brands of America Inc	2644ba07-aaee-6402-e063-6394a90a2827	2025-08-06	Warnings	Exact identifier application number: M005
Anti- Fungal Miconazole Nitrate	MICONAZOLE NITRATE	Premier Brands of America Inc.	f186bdc1-db6c-0fab-e053-2995a90a7c58	2025-08-06	Warnings	Exact identifier application number: M005
ONIADBA Fungal Nail Treatment Swabs	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3baa99ab-6d22-8d7d-e063-6294a90af3e8	2025-08-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	cca84334-2e2d-4991-9d1e-d5b7c9ffd392	2025-08-01	Warnings	Exact identifier application number: M005
RoyceDerm CoolDefense Refreshing Shower Gel	TOLNAFTATE 1.0%	RoyceDerm LLC	3b3216d6-8cc8-ea89-e063-6294a90ab691	2025-07-31	Warnings	Exact identifier application number: M005
SUNMARK MICONAZOLE NITRATE antifungal	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	7c15d95a-5b89-4789-8c91-3f61d7ec7707	2025-07-30	Warnings	Exact identifier application number: M005
Antifungal	MICONAZOLE NITRATE	Advanced Rx LLC	e13eb653-3916-444a-ae86-1738c0308b79	2025-07-28	Warnings	Exact identifier application number: M005

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	96a40ccd-17f7-4e4e-98da-207802fa2b2d	8
103951	tolnaftate 10 MG/ML Topical Cream	SCD	96a40ccd-17f7-4e4e-98da-207802fa2b2d	8
103951	tolnaftate 1 % Topical Cream	SY	96a40ccd-17f7-4e4e-98da-207802fa2b2d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69396-016-33	69396001633	3 TUBE in 1 BOX (69396-016-33) / 30 g in 1 TUBE	3 tube	2025-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolnaftate Cream 1% ANTIFUNGAL CREAM	Trifecta Pharmaceuticals Usa Llc	2025-05-15	HUMAN OTC DRUG LABEL	8