Natural Vaginal Care

Product NDC
49589-115
11-digit product format
495890115
Labeler code
49589
Product ID
49589-115_7a7247e7-5513-4c7b-baf9-680eac576525
Type
HUMAN OTC DRUG
Nonproprietary name
Sambucus nigra flower, Echinacea purpurea, and Centella Asiatica
Dosage form
CREAM
Route
VAGINAL
Labeler
Izun Pharmaceuticals Corporation
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-05-29
Marketing end
0000-00-00
Substance
SAMBUCUS NIGRA FLOWER; ECHINACEA PURPUREA; CENTELLA ASIATICA
Active strength
2 [hp_X]/2.5g; [hp_X]/2.5g; [hp_X]/2.5g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct49589-115IInactivated by FDA2026-11-03
excluded packagepackage49589-11549589-115-60IInactivated by FDA2026-11-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49589-115-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49589-115-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49589-115-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49589-115-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49589-115-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49589-115-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49589-115-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49589-115-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49589-115-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49589-115-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49589-115-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49589-115-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49589-115-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49589-115-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49589-115-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49589-115-60IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49589-115-60IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49589-115-60IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49589-115-60IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49589-115-60IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49589-115-60IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49589-115-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49589-115-602020-01-31C16284748780-19d75b9d0-1a3b-f424-e053-dadaa90a57ceNatural Vaginal Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49589-115-60Natural Vaginal Care40 g in 1 TUBE, WITH APPLICATORCREAM402
49589-115-60Natural Vaginal Care1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Centella AsiaticaACTIVE INGREDIENT7M867G6T1UNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
Echinacea purpureaACTIVE INGREDIENTQI7G114Y98NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
Sambucus nigra flowerACTIVE INGREDIENT07V4DX094TNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
Centella AsiaticaACTIVE MOIETY7M867G6T1UNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
Echinacea purpureaACTIVE MOIETYQI7G114Y98NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
Sambucus nigra flowerACTIVE MOIETY07V4DX094TNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
hypromellose 2208 (15000 mpa.s)INACTIVE INGREDIENTZ78RG6M2N2NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2
waterINACTIVE INGREDIENT059QF0KO0RNATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49589-115NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2Legacy NDC, 2 package rows20150529_a74d5d68-5e31-4126-9987-64dc1fd1521e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49589-115-604958901156040 g in 1 TUBE, WITH APPLICATOR40 gHistorical