FDA.reportPublic FDA data

basic care miconazole 3

Product NDC
72288-070
11-digit product format
722880070
Labeler code
72288
Product ID
72288-070_e1457c13-6d35-41b2-b1e8-7e82b647a0c7
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Amazon.com Services LLC
Application
ANDA091366
Marketing category
ANDA
Marketing start
2021-07-15
Substance
MICONAZOLE NITRATE
Active strength
40 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
A091366-001MICONAZOLE NITRATEMICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15

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 22:54:322026-06A091366-001MICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD SENSE MICONAZOLE 3MICONAZOLE NITRATEL. Perrigo Company906dcf48-63d8-44cf-a699-d1f30c84a0292025-11-29WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
miconazole 3MICONAZOLE NITRATEWalgreen Company0600418d-77ec-4f2d-a08e-1bf5ec6349042025-01-27WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
basic care miconazole 3MICONAZOLE NITRATEAmazon.com Services LLCe1457c13-6d35-41b2-b1e8-7e82b647a0c72021-07-26WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 72288-070
HERS Miconazole 3MICONAZOLE NITRATEHims Inc1b2a36fb-48dd-451e-a804-c864be4e53262021-03-04WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
Topco Miconazole 3MICONAZOLE NITRATETopco Associates LLCaef7be88-3cd7-484b-96a3-e9bbeca55e2a2021-02-10WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
MiconazoleMICONAZOLE NITRATEH E B83305fd6-2154-4b1b-aaec-3e2e56708fdb2021-02-09WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366

Additional Listing Data#

Finished product
Yes
Brand name base
basic care miconazole 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998544Internal RxNorm lookup
2288429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1457c13-6d35-41b2-b1e8-7e82b647a0c7Available 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
72288-070-14basic care miconazole 33 in 1 CARTONCREAM31
72288-070-14basic care miconazole 35 g in 1 APPLICATORCREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-070BASIC CARE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20210728_e1457c13-6d35-41b2-b1e8-7e82b647a0c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288429{3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCKe1457c13-6d35-41b2-b1e8-7e82b647a0c71
2288429miconazole 4 % Vaginal Cream 3-Day Applicator PackPSNe1457c13-6d35-41b2-b1e8-7e82b647a0c71
998544miconazole nitrate 4 % Vaginal CreamPSNe1457c13-6d35-41b2-b1e8-7e82b647a0c71
998544miconazole nitrate 40 MG/ML Vaginal CreamSCDe1457c13-6d35-41b2-b1e8-7e82b647a0c71
2288429miconazole 4 % 3-Day Prefilled Applicator PackSYe1457c13-6d35-41b2-b1e8-7e82b647a0c71
998544miconazole nitrate 4 % Vaginal CreamSYe1457c13-6d35-41b2-b1e8-7e82b647a0c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-070-14722880070143 APPLICATOR in 1 CARTON (72288-070-14) / 5 g in 1 APPLICATOR3 applicator2021-07-150000-00-00NoNoCurrent