miconazole 1

Product NDC
41250-199
11-digit product format
412500199
Labeler code
41250
Product ID
41250-199_a1402e67-6674-4ba0-95c4-818153ce429a
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Meijer Distribution Inc
Application
ANDA079114
Marketing category
ANDA
Marketing start
2010-06-11
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079114-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32025-10-01WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
equate miconazole 1MICONAZOLE NITRATEWal-Mart Stores Inc5c5b0486-9ec2-4e14-a35c-80da8e62c59e2025-07-02WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEMeijer Distribution Incc34d9917-ee79-4afb-9338-6f18e63b2b092025-01-13WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 41250-199
up and up miconazoleMICONAZOLE NITRATETarget Corporationb626313a-b8aa-43fe-b8a9-475009ea5b532024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1 yeast infection reliefMICONAZOLE NITRATECVS Pharmacyb0e5320b-73d5-4e96-8ce4-9a858e9d2ed32024-12-10WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Basic Care MiconazoleMICONAZOLE NITRATEAmazon.com Services LLC962bef75-1583-4782-bfba-52a68876eedc2024-11-04WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
careone miconazole 1MICONAZOLE NITRATEAmerican Sales Companyf51af8e2-fb06-4842-8021-b7efd515022e2023-10-23WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
exchange select miconazole 1MICONAZOLE NITRATEArmy & Air Force Exchange Service672d935f-0807-44d1-8faa-94d4169070952022-11-29WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Signature Care Miconazole 1MICONAZOLE NITRATESafeway5129e042-421e-41e3-a0be-90f12d12b40b2022-11-15WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEH E B40cc911b-2c35-4382-a979-fb1a165049db2022-11-12WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Good Neighbor Pharmacy Miconazole 1MICONAZOLE NITRATEAmerisource Bergen12c400dc-4fbf-4a10-9a4d-5156d65b509a2022-11-09WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114

Additional Listing Data#

Finished product
Yes
Brand name base
miconazole 1
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992774Internal RxNorm lookup
992775Internal RxNorm lookup
998483Internal RxNorm lookup
998540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c34d9917-ee79-4afb-9338-6f18e63b2b09Available on FDA.report

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
41250-199-00miconazole 11 in 1 CARTONKIT18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
GELATININACTIVE INGREDIENT2G86QN327LMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-199MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 1 package rows20250122_c34d9917-ee79-4afb-9338-6f18e63b2b09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCKc34d9917-ee79-4afb-9338-6f18e63b2b098
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSNc34d9917-ee79-4afb-9338-6f18e63b2b098
992774miconazole nitrate 1200 MG Vaginal InsertPSNc34d9917-ee79-4afb-9338-6f18e63b2b098
998483miconazole nitrate 2 % Topical CreamPSNc34d9917-ee79-4afb-9338-6f18e63b2b098
998540miconazole nitrate 2 % Vaginal CreamPSNc34d9917-ee79-4afb-9338-6f18e63b2b098
992774miconazole nitrate 1200 MG Vaginal InsertSCDc34d9917-ee79-4afb-9338-6f18e63b2b098
998483miconazole nitrate 20 MG/ML Topical CreamSCDc34d9917-ee79-4afb-9338-6f18e63b2b098
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDc34d9917-ee79-4afb-9338-6f18e63b2b098
992774miconazole nitrate 1.2 GM Vaginal InsertSYc34d9917-ee79-4afb-9338-6f18e63b2b098
998483miconazole nitrate 2 % Topical CreamSYc34d9917-ee79-4afb-9338-6f18e63b2b098
998540miconazole nitrate 2 % Vaginal CreamSYc34d9917-ee79-4afb-9338-6f18e63b2b098

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-199-00412500199001 KIT in 1 CARTON (41250-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE1 kit2010-06-110000-00-00NoNoCurrent