Tolnaftate Cream 1% ANTIFUNGAL

Product NDC: 69396-016
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 39 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terrasil Anti-Fungal Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	db356cc8-f473-4eb2-b8d8-72606fca9dc0	2025-05-23	Warnings	Exact identifier application number: M005
terrasil Folliculitis Cream Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d54756-00dd-bbe1-e063-6394a90a9e02	2025-05-23	Warnings	Exact identifier application number: M005
Paume Moisturizing Antibacterial Hand Gel	ALCOHOL	Paume Inc	b6fe12bf-6430-5861-e053-2a95a90a6c8f	2025-05-22	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	Trifecta Pharmaceuticals Usa Llc	96a40ccd-17f7-4e4e-98da-207802fa2b2d	2025-05-15	Warnings	Exact identifier application number: M005 ndc (product): 69396-016
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Cardinal Health 110 dba LEADER	34f4c733-2eb2-0db0-e063-6394a90a6431	2025-05-13	Warnings	Exact identifier application number: M005
Dr CANUSO fungal nail eraser	TOLNAFTATE OIL	Renu Laboratories, LLC	2083f9ed-09d6-26e6-e054-00144ff88e88	2025-05-13	Warnings	Exact identifier application number: M005
Dr. Canuso foot repair serum	TOLNAFTATE SERUM	Renu Laboratories, LLC	1fcc52c5-7030-13cb-e054-00144ff8d46c	2025-05-13	Warnings	Exact identifier application number: M005
Private Label Antifungal Barrier Cream	MICONAZOLE NITRATE ANTIFUNGAL CREAM	Swiss-American CDMO, LLC	2ee40c37-504b-43ed-960a-535015407492	2025-05-09	Warnings	Exact identifier application number: M005
Osimoon Fungal Nail Treatment Kit	OSIMOON FUNGAL NAIL TREATMENT KIT	Guangzhou Zanming Trading Co., Ltd.	34aec10d-a0d0-d956-e063-6394a90a39b2	2025-05-09	Warnings	Exact identifier application number: M005
ANTIFUNGAL	MICONAZOLE	VIVE HEALTH LLC	33d9c724-d4c4-2597-e063-6294a90aa5f3	2025-04-28	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	VIVE HEALTH LLC	33db98f5-f6d9-742a-e063-6394a90a2a03	2025-04-28	Warnings	Exact identifier application number: M005
Foot Cure Nail Repair Pen	ANTIFUNGAL NAIL REPAIR PEN	SANSAR, LLC	9c823e27-8bb3-4ccd-bf7e-a99d45908e88	2025-04-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER CUCUMBER MELON	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380404d-9499-e9fb-e063-6394a90a0f27	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUT	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380fe6d-e059-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3381cefb-281c-9b85-e063-6294a90acfd9	2025-04-24	Warnings	Exact identifier application number: M005
Wish Hand Sanitizer Coconut Cream White Florals	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33826aef-6e50-2730-e063-6394a90a727b	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER GOLDEN CITRUS	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3391a78e-525d-c2ba-e063-6394a90a1e99	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIO	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33927939-a9dc-ab67-e063-6394a90a71cc	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLA	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	336c751f-6a33-ca55-e063-6394a90a9749	2025-04-23	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOOD	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	337e4526-238a-bc2d-e063-6394a90a5a27	2025-04-23	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	Marketing end	Sample	Exclude flag	Status
69396-016-05	69396001605	1 TUBE in 1 BOX (69396-016-05) / 15 g in 1 TUBE	1 tube	2016-04-09	0000-00-00	No	No	Current
69396-016-20	69396001620	1 TUBE in 1 BOX (69396-016-20) / 30 g in 1 TUBE	1 tube	2016-04-09	0000-00-00	No	No	Current
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
69396-016-66	69396001666	6 TUBE in 1 BOX (69396-016-66) / 30 g in 1 TUBE	6 tube	2023-06-20		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