FDA.reportPublic FDA data

dg health miconazole 3

Product NDC
55910-081
11-digit product format
559100081
Labeler code
55910
Product ID
55910-081_22ecb5ef-b5d6-4520-ab11-01813fc9bbc4
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Dolgencorp Inc
Application
ANDA075329
Marketing category
ANDA
Marketing start
2010-02-22
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 3
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 998483, 998540

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
55910-081-00dg health miconazole 31 in 1 CARTONKIT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-081DG HEALTH MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [DOLGENCORP INC]3Current NDC, Legacy NDC, 1 package rows20210928_d84aa78d-b408-4d51-a54c-c66f6cef33f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKd84aa78d-b408-4d51-a54c-c66f6cef33f14
998483miconazole nitrate 2 % Topical CreamPSNd84aa78d-b408-4d51-a54c-c66f6cef33f14
998540miconazole nitrate 2 % Vaginal CreamPSNd84aa78d-b408-4d51-a54c-c66f6cef33f14
992765miconazole nitrate 200 MG Vaginal InsertPSNd84aa78d-b408-4d51-a54c-c66f6cef33f14
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNd84aa78d-b408-4d51-a54c-c66f6cef33f14
998483miconazole nitrate 20 MG/ML Topical CreamSCDd84aa78d-b408-4d51-a54c-c66f6cef33f14
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDd84aa78d-b408-4d51-a54c-c66f6cef33f14
992765miconazole nitrate 200 MG Vaginal InsertSCDd84aa78d-b408-4d51-a54c-c66f6cef33f14
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYd84aa78d-b408-4d51-a54c-c66f6cef33f14
992766miconazole 3 Day Vaginal Insert Combination PackSYd84aa78d-b408-4d51-a54c-c66f6cef33f14
998483miconazole nitrate 2 % Topical CreamSYd84aa78d-b408-4d51-a54c-c66f6cef33f14
998540miconazole nitrate 2 % Vaginal CreamSYd84aa78d-b408-4d51-a54c-c66f6cef33f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-081-00559100081001 KIT in 1 CARTON (55910-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2010-02-220000-00-00NoNoCurrent