FDA.reportPublic FDA data

DERMAFUNGAL

Product NDC
61924-234
Requested package NDC
61924-234-04
11-digit product format
619240234
Labeler code
61924
Product ID
61924-234_d58c93cb-4fa9-83f9-e053-2a95a90a7632
Type
HUMAN OTC DRUG
Nonproprietary name
ANTIMICROBIAL DRUG PRODUCTS
Dosage form
CREAM
Route
TOPICAL
Labeler
DermaRite industries, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-12-12
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
0 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage61924-23461924-234-04IInactivated by FDA2026-10-12

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
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61924-234-042026-01-29DRUG LISTING: DERMAFUNGAL
61924-234-052026-01-29DRUG LISTING: DERMAFUNGAL
61924-234-042024-12-06DRUG LISTING: DERMAFUNGAL
61924-234-052024-12-06DRUG LISTING: DERMAFUNGAL
61924-234-042024-01-30DRUG LISTING: DERMAFUNGAL
61924-234-052024-01-30DRUG LISTING: DERMAFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-234-04DERMAFUNGAL106 g in 1 TUBECREAM1069
61924-234-05DERMAFUNGAL5 g in 1 PACKETCREAM59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-234-04GM - Gram61924-234f971cbea-9b8b-4a5b-83c5-5f3f156c472a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
PEG-40 Castor OilINACTIVE INGREDIENT4ERD2076EFDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEDERMAGUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-234DERMAFUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]9Legacy NDC, 2 package rows20241208_4e7739a1-cff0-4b76-94f0-d9f9af158df5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-234-0461924023404106 g in 1 TUBE (61924-234-04) 106 g2005-12-120000-00-00NoNoCurrent