FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
61269-735
Requested package NDC
61269-735-14
11-digit product format
612690735
Labeler code
61269
Product ID
61269-735_f5d7edd7-387b-4a84-af3c-1d7a78df5c0d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
H2-Pharma, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-29
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61269-73561269-735-14DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-735-14GM - Gram61269-735d8f29709-852e-47b8-aa8b-855bed7d7ff512021-07-15
61269-735-42GM - Gram61269-7350120fd90-5843-41fa-beea-8e0b2780984112021-07-15
61269-735-56GM - Gram61269-73547f4642f-3ed7-47e4-933e-190f35e5bbf512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-735MICONAZOLE NITRATE CREAM [H2-PHARMA, LLC]3Legacy NDC20250101_3bfb86ec-55b0-4151-9b74-7243a55dca67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN7a0ef38a-9584-4e67-ba86-c31f86da1ed06
998483miconazole nitrate 2 % Topical CreamPSN7d284f6f-a970-49fe-b45a-d5c6c2688bc26
998483miconazole nitrate 20 MG/ML Topical CreamSCD7a0ef38a-9584-4e67-ba86-c31f86da1ed06
998483miconazole nitrate 20 MG/ML Topical CreamSCD7d284f6f-a970-49fe-b45a-d5c6c2688bc26
998483miconazole nitrate 2 % Topical CreamSY7a0ef38a-9584-4e67-ba86-c31f86da1ed06
998483miconazole nitrate 2 % Topical CreamSY7d284f6f-a970-49fe-b45a-d5c6c2688bc26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61269-735-14612690735141 TUBE in 1 CARTON (61269-735-14) > 14 g in 1 TUBE1 tube2021-06-290000-00-00NoNoCurrent