FDA.reportPublic FDA data

Mycozyl HC

Product NDC
59088-264
Requested package NDC
59088-264-03
11-digit product format
590880264
Labeler code
59088
Product ID
59088-264_0c407982-192e-4c61-e063-6294a90a05d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolnaftate, Hydrocortisone
Dosage form
LIQUID
Route
TOPICAL
Labeler
PURETEK CORPORATION
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-11
Substance
TOLNAFTATE; HYDROCORTISONE
Active strength
.1; .0667 g/10mL; g/10mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 HC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.1 g/10mL
HYDROCORTISONE.0667 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c407982-192f-4c61-e063-6294a90a05d7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-264-03Mycozyl HC30 mL in 1 BOTTLELIQUID301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-264-03ML - Milliliter59088-264991b6f0e-634f-4987-aa6b-12af69c7a8ac12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-264MYCOZYL HC (TOLNAFTATE, HYDROCORTISONE) LIQUID [PURETEK CORPORATION]1Current NDC, 1 package rows20231212_0c407982-192f-4c61-e063-6294a90a05d7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycozyl HCTOLNAFTATE, HYDROCORTISONEPURETEK CORPORATION0c407982-192f-4c61-e063-6294a90a05d72023-12-11Warnings, Adverse reactionsExact identifier
ndc (package): 59088-264-03
ndc (product): 59088-264
ndc11 (package): 59088026403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671298hydrocortisone 0.667 % / tolnaftate 1 % Topical SolutionPSN0c407982-192f-4c61-e063-6294a90a05d71
2671298hydrocortisone 6.67 MG/ML / tolnaftate 10 MG/ML Topical SolutionSCD0c407982-192f-4c61-e063-6294a90a05d71
2671298hydrocortisone 0.667 % / tolnaftate 1 % Topical SolutionSY0c407982-192f-4c61-e063-6294a90a05d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-264-035908802640330 mL in 1 BOTTLE (59088-264-03) 30 ml2023-12-11NoNoCurrent