FDA.reportPublic FDA data

Vytone

Product NDC
57893-302
Requested package NDC
57893-302-10
11-digit product format
578930302
Labeler code
57893
Product ID
57893-302_60c85e6b-e5b1-09c2-e053-2a91aa0a9460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE ACETATE, IODOQUINOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Artesa Labs, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-07-29
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE; IODOQUINOL
Active strength
19 mg/g; mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57893-30257893-302-10DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57893-302-01GM - Gram57893-3023227982a-9439-4d75-9c99-ed73708c771e12015-07-20
57893-302-30GM - Gram57893-302d2316e01-a435-4d29-8ef3-d9b29a57d92512013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
IODOQUINOLACTIVE INGREDIENT63W7IE88K8VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
IODOQUINOLACTIVE MOIETY63W7IE88K8VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
POLACRILININACTIVE INGREDIENTRCZ785HI7SVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
PPG-20 METHYL GLUCOSE ETHERINACTIVE INGREDIENT3WV1T97D3KVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RVYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ARTESA LABS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57893-302-105789303021010 PACKET in 1 CARTON (57893-302-10) > 2 g in 1 PACKET (57893-302-01) 10 packet2011-07-290000-00-00YesNoCurrent