FDA.reportPublic FDA data

Miconazole

Product NDC
68016-291
11-digit product format
680160291
Labeler code
68016
Product ID
68016-291_421e11c4-085b-4f3d-bbbc-079d4ea522fc
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-05-15
Marketing end
2026-12-31
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-291-01Miconazole1 in 1 CARTONCREAM112
68016-291-01Miconazole28 g in 1 TUBECREAM2812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-291-01GM - Gram68016-2911e8b2dde-5c7f-4ebb-af84-ceea0b380a2112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-291MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]11Current NDC, Legacy NDC, 2 package rows20231007_246be926-79ea-4e0c-a3ef-2aa7fc3a52bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN246be926-79ea-4e0c-a3ef-2aa7fc3a52bf12
998483miconazole nitrate 20 MG/ML Topical CreamSCD246be926-79ea-4e0c-a3ef-2aa7fc3a52bf12
998483miconazole nitrate 2 % Topical CreamSY246be926-79ea-4e0c-a3ef-2aa7fc3a52bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-291-01680160291011 TUBE in 1 CARTON (68016-291-01) / 28 g in 1 TUBE1 tube2009-05-152026-12-31NoNoCurrent