Stomasin

Product NDC
82871-301
Requested package NDC
82871-301-01
11-digit product format
828710301
Labeler code
82871
Product ID
82871-301_edf82092-7baa-7598-e053-2995a90a8eaf
Type
HUMAN OTC DRUG
Nonproprietary name
Gypsum fibrosum extract, Forsythia viridissima fruit extract, Arctium lappa fruit extract, Platycodon grandiflorus root extract, Saposhnikovia divaricata root extract, Glycyrrhiza uralensis root extract, Ostericum koreanum extract, Schizonepeta tenuifolia extract
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
MedicareBio.Co.Ltd
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-07-13
Marketing end
0000-00-00
Substance
ARCTIUM LAPPA FRUIT; CALCIUM SULFATE, UNSPECIFIED FORM; FORSYTHIA VIRIDISSIMA FRUIT; GLYCYRRHIZA URALENSIS ROOT; NEPETA TENUIFOLIA FLOWERING TOP; OSTERICUM GROSSESERRATUM ROOT; PLATYCODON GRANDIFLORUM ROOT; SAPOSHNIKOVIA DIVARICATA ROOT
Active strength
500 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82871-30182871-301-01IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82871-301-012025-01-30C16284748780-12cef2736-5f2a-d83d-e063-dadaa90ab31f82871-301-01 Stomasin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82871-301-01Stomasin10 in 1 BLISTER PACKCAPSULE, COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82871-301STOMASIN (GYPSUM FIBROSUM EXTRACT, FORSYTHIA VIRIDISSIMA FRUIT EXTRACT, ARCTIUM LAPPA FRUIT EXTRACT, PLATYCODON GRANDIFLORUS ROOT EXTRACT, SAPOSHNIKOVIA DIVARICATA ROOT EXTRACT, GLYCYRRHIZA URALENSIS ROOT EXTRACT, OSTERICUM KOREANUM EXTRACT, SCHIZONEPETA TENUIFOLIA EXTRACT) CAPSULE, COATED [MEDICAREBIO.CO.LTD]4Legacy NDC, 1 package rows20231228_e3ac2145-22c6-eefe-e053-2995a90aaf17.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82871-301-018287103010110 CAPSULE, COATED in 1 BLISTER PACK (82871-301-01) 2022-07-130000-00-00NoNoCurrent