Signature Care miconazole 1

Product NDC
21130-737
Requested package NDC
21130-737-45
11-digit product format
211300737
Labeler code
21130
Product ID
21130-737_bac509a0-2806-418f-a36e-3023f30a7b79
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Safeway
Application
ANDA079114
Marketing category
ANDA
Marketing start
2018-07-11
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-73721130-737-45DDiscontinued 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
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.

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 UTC2026-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-023f01610625f2…
2019-09-15 20:21 UTC2019-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-737SIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1Legacy NDC20180830_bac509a0-2806-418f-a36e-3023f30a7b79.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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-737-45211300737451 KIT in 1 CARTON (21130-737-45) * 1 INSERT in 1 POUCH * 9 g in 1 TUBE1 kit2018-07-110000-00-00NoNoCurrent