DG Health Miconazole

Product NDC
55910-698
11-digit product format
559100698
Labeler code
55910
Product ID
55910-698_8c3aedbe-c817-4088-85ea-79a3128c056d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Dolgencorp, LLC
Application
ANDA074760
Marketing category
ANDA
Marketing start
2020-03-18
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DG Health Miconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540

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
55910-698-29DG Health Miconazole1 in 1 CARTONCREAM12
55910-698-29DG Health Miconazole45 g in 1 TUBECREAM452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-698DG HEALTH MICONAZOLE (MICONAZOLE NITRATE) CREAM [DOLGENCORP, LLC]2Current NDC, Legacy NDC, 2 package rows20210615_12a36975-ebfe-4fcb-a9de-981a21325632.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN12a36975-ebfe-4fcb-a9de-981a213256322
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD12a36975-ebfe-4fcb-a9de-981a213256322
998540miconazole nitrate 2 % Vaginal CreamSY12a36975-ebfe-4fcb-a9de-981a213256322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-698-29559100698291 TUBE in 1 CARTON (55910-698-29) / 45 g in 1 TUBE1 tube2020-03-180000-00-00NoNoCurrent