Osteodin-Z

Product NDC
69825-001
11-digit product format
698250001
Labeler code
69825
Product ID
69825-001_85e6cf14-8fd5-44d5-a8ae-b9460ff6eab8
Type
HUMAN OTC DRUG
Nonproprietary name
Dulcamara, Amica Montana, Ruta gravelolens, Rhus toxicodendron, Actaea racemosa, Formica rufa
Dosage form
LIQUID
Route
ORAL
Labeler
Adven Biotech Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-05-18
Marketing end
0000-00-00
Substance
SOLANUM DULCAMARA TOP; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; FORMICA RUFA; ACTAEA RACEMOSA WHOLE; ARNICA MONTANA
Active strength
3 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL
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 productproduct69825-001IInactivated by FDA2026-10-15
excluded packagepackage69825-00169825-001-02IInactivated by FDA2026-10-15

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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02IInactivated 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 packagepackage69825-001-02EExcluded 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
69825-001-022020-01-31C16284748780-19d75b9d0-1a05-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69825-001-01Osteodin-Z30 mL in 1 BOTTLELIQUID301
69825-001-02Osteodin-Z2 in 1 CARTONLIQUID21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTAEA RACEMOSA WHOLEACTIVE INGREDIENTSS9QP678NGOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
FORMICA RUFAACTIVE INGREDIENT55H0W83JO5OSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7AOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
ACTAEA RACEMOSA WHOLEACTIVE MOIETYSS9QP678NGOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
FORMICA RUFAACTIVE MOIETY55H0W83JO5OSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7AOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0ROSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69825-001OSTEODIN-Z (DULCAMARA, AMICA MONTANA, RUTA GRAVELOLENS, RHUS TOXICODENDRON, ACTAEA RACEMOSA, FORMICA RUFA) LIQUID [ADVEN BIOTECH PRIVATE LIMITED]1Legacy NDC, 2 package rows20150526_ae51ed27-6e66-4a00-a112-4e8fc59541b5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69825-001-016982500010130 mL in 1 BOTTLE30 mlHistorical
69825-001-02698250001022 in 1 CARTONHistorical