FDA.reportPublic FDA data

Miconazole 3 Combination Pack

Product NDC
11822-7310
11-digit product format
118227310
Labeler code
11822
Product ID
11822-7310_68bb3e9b-74bd-4305-a60a-515d4c2925b3
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Rite Aid Corporation
Application
ANDA074926
Marketing category
ANDA
Marketing start
2001-03-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-7310DDiscontinued by firm2026-08-03
excluded packagepackage11822-731011822-7310-7DDiscontinued by firm2026-08-03

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
A074926-001M-ZOLE 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16cb3db0bc1861…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7310MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]7Legacy NDC20221217_0ec760e8-fb33-423b-b3be-52fc09d18fd5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3 Combination PackMICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc2025-09-08WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
Miconazole 3 Combination PackMICONAZOLE NITRATEChain Drug Consortium, LLCd01f7ef9-4f04-4874-a625-0335f6392b732025-09-05WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitMICONAZOLE NITRATECosette Pharmaceuticals, Inc.eed88487-a7ba-4853-8519-13f92ed5539f2025-01-06WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
Miconazole 3 Combination PackMICONAZOLE NITRATECVS Pharmacy65c99592-7c11-41fc-8296-aad0a8f399262023-01-18WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-7310-7118227310071 KIT in 1 PACKAGE, COMBINATION (11822-7310-7) * 9 g in 1 TUBE * 3 SUPPOSITORY in 1 BLISTER PACK1 kit2001-03-010000-00-00NoNoCurrent