FDA.reportPublic FDA data

Miconazole 3 Combination Pack

Product NDC
49035-731
11-digit product format
490350731
Labeler code
49035
Product ID
49035-731_c8035528-071f-40b6-8c0e-68e440e40a18
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
EQUATE (Wal-Mart Stores, Inc.)
Application
ANDA074926
Marketing category
ANDA
Marketing start
2007-06-11
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct49035-731DDiscontinued by firm2026-08-03
excluded packagepackage49035-73149035-731-43DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-731-43d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-731-43f5e01cc5f278…a2eaf40c39c3…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [WAL-MART STORES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-731MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Legacy NDC20230120_bb542dd6-560a-4dd3-9974-69209c6d1cef.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
49035-731-43490350731431 KIT in 1 PACKAGE, COMBINATION (49035-731-43) * 9 g in 1 TUBE * 3 SUPPOSITORY in 1 BLISTER PACK1 kit2007-06-110000-00-00NoNoCurrent