Mycozyl AL

Product NDC: 59088-443
11-digit product format: 590880443
Labeler code: 59088
Product ID: 59088-443_07edd043-4ac5-b2de-e063-6394a90af25d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolnaftate
Dosage form: LIQUID
Route: TOPICAL
Labeler: PURETEK CORPORATION
Application: M005
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2023-10-17
Substance: TOLNAFTATE
Active strength: .1 g/10mL
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: Mycozyl AL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	.3 g/30mL

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
313423	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
b82c9a8a-f6f1-dca6-e053-2995a90a47f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-443-03	Mycozyl AL	30 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	30		3
59088-443-03	Miconatate	30 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	1 mL in 30	0.3 g in 30mL	3
59088-443-01	Mycozyl AL	10 mL in 1 BOTTLE	LIQUID	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59088-443-03	ML - Milliliter	59088-443	958250a3-49e2-439f-998a-bf21bf22ea52	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59088-443	MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]	3	Current NDC, Legacy NDC	20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip
59088-443	MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]	3	Current NDC, Legacy NDC, 1 package rows	20241004_b82c9a8a-f6f1-dca6-e053-2995a90a47f9.zip
59088-443	MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]	1	Current NDC, Legacy NDC, 1 package rows	20231018_07edd043-4ac4-b2de-e063-6394a90af25d.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 · 974 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
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
998461	miconazole nitrate 2 % Topical Powder	PSN	c45c8f8f-9042-a428-e053-2a95a90acda9	3
313423	tolnaftate 1 % Topical Solution	PSN	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	3
313423	tolnaftate 1 % Topical Solution	PSN	c45c8f8f-9042-a428-e053-2a95a90acda9	3
998461	miconazole nitrate 0.02 MG/MG Topical Powder	SCD	c45c8f8f-9042-a428-e053-2a95a90acda9	3
313423	tolnaftate 10 MG/ML Topical Solution	SCD	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	3
313423	tolnaftate 10 MG/ML Topical Solution	SCD	c45c8f8f-9042-a428-e053-2a95a90acda9	3
998461	miconazole nitrate 2 % Topical Powder	SY	c45c8f8f-9042-a428-e053-2a95a90acda9	3
313423	tolnaftate 1 % Topical Solution	SY	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	3
313423	tolnaftate 1 % Topical Solution	SY	c45c8f8f-9042-a428-e053-2a95a90acda9	3
313423	tolnaftate 1 % Topical Solution	PSN	07edd043-4ac4-b2de-e063-6394a90af25d	1
313423	tolnaftate 10 MG/ML Topical Solution	SCD	07edd043-4ac4-b2de-e063-6394a90af25d	1
313423	tolnaftate 1 % Topical Solution	SY	07edd043-4ac4-b2de-e063-6394a90af25d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59088-443-01	59088044301	10 mL in 1 BOTTLE (59088-443-01)	10 ml	2023-10-17		No	No	Current
59088-443-03	59088044303	30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03)	30 ml	2021-06-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Miconatate	PureTek Corporation	2024-10-16	HUMAN OTC DRUG LABEL	3
Mycozyl AL™ Tolnaftate 1% Antifungal Liquid	PureTek Corporation	2024-10-02	HUMAN OTC DRUG LABEL	3
Mycozyl AL	PURETEK CORPORATION	2023-10-17	HUMAN PRESCRIPTION DRUG LABEL	1