FDA.reportPublic FDA data

Good Sense Miconazole 3

Product NDC
0113-0081
11-digit product format
001130081
Labeler code
0113
Product ID
0113-0081_791ad24a-cafd-46c8-87d7-9ad3351452ee
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
L. Perrigo Company
Application
ANDA075329
Marketing category
ANDA
Marketing start
2007-04-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense 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
0113-0081-00Good Sense Miconazole 31 in 1 CARTONKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0081-00EA - Each0113-00812981cba2-0db2-49b0-a8c4-f6833494964312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4GOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50GOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5GOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0081GOOD SENSE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 1 package rows20250516_9aeac709-001b-4617-8046-186264847ec8.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) } PackGPCK9aeac709-001b-4617-8046-186264847ec85
998483miconazole nitrate 2 % Topical CreamPSN9aeac709-001b-4617-8046-186264847ec85
998540miconazole nitrate 2 % Vaginal CreamPSN9aeac709-001b-4617-8046-186264847ec85
992765miconazole nitrate 200 MG Vaginal InsertPSN9aeac709-001b-4617-8046-186264847ec85
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN9aeac709-001b-4617-8046-186264847ec85
998483miconazole nitrate 20 MG/ML Topical CreamSCD9aeac709-001b-4617-8046-186264847ec85
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9aeac709-001b-4617-8046-186264847ec85
992765miconazole nitrate 200 MG Vaginal InsertSCD9aeac709-001b-4617-8046-186264847ec85
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY9aeac709-001b-4617-8046-186264847ec85
992766miconazole 3 Day Vaginal Insert Combination PackSY9aeac709-001b-4617-8046-186264847ec85
998483miconazole nitrate 2 % Topical CreamSY9aeac709-001b-4617-8046-186264847ec85
998540miconazole nitrate 2 % Vaginal CreamSY9aeac709-001b-4617-8046-186264847ec85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0081-00001130081001 KIT in 1 CARTON (0113-0081-00) * 1 BLISTER PACK in 1 KIT / 3 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2007-04-020000-00-00NoNoCurrent