Colostat

Product NDC
44911-0411
11-digit product format
449110411
Labeler code
44911
Product ID
44911-0411_04e60dcd-8168-4d44-b7a0-8949a93010a7
Type
HUMAN OTC DRUG
Nonproprietary name
Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-12-30
Marketing end
2027-04-13
Substance
ALUMINUM OXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; CAJUPUT OIL; CINCHONA OFFICINALIS BARK; FRANGULA PURSHIANA BARK; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANDRAGORA OFFICINARUM ROOT; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
12; 12; 6; 12; 3; 6; 12; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Current FDA listing
Yes

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage44911-0411-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0411-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0411-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0411-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0411-11332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage44911-0411-18dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Colostat

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FRANGULA PURSHIANA BARK3 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
CAJUPUT OIL6 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
ALUMINUM OXIDE12 [hp_X]/mL
ARTEMISIA CINA PRE-FLOWERING TOP12 [hp_X]/mL
CINCHONA OFFICINALIS BARK12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]/mL
MANDRAGORA OFFICINARUM ROOT12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4VBP01X99FInternal UNII lookup
WYT05213GEInternal UNII lookup
39981FM375Internal UNII lookup
J3TO6BUQ37Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
LMI26O6933Internal UNII lookup
28M1820ACTInternal UNII lookup
S003A158SBInternal UNII lookup
C88X29Y479Internal UNII lookup
HF539G9L3QInternal UNII lookup
I2XCB174VBInternal UNII lookup
269XH13919Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89c86e7b-304c-43a6-81e7-373d95c9fac1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-10-24DRUG FACTS:
2024-10-24DRUG FACTS:
2024-01-30DRUG FACTS:
2024-01-30DRUG FACTS:
2022-02-08DRUG FACTS:
2022-02-08DRUG FACTS:
2021-01-29DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0411-1Colostat30 mL in 1 BOTTLE, DROPPERLIQUID308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0411COLOSTAT (RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA) LIQUID [ENERGIQUE, INC.]7Current NDC, Legacy NDC, 1 package rows20241027_89c86e7b-304c-43a6-81e7-373d95c9fac1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICAEnergique, Inc.89c86e7b-304c-43a6-81e7-373d95c9fac12025-10-06WarningsExact identifier
ndc (product): 44911-0411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0411-14491104110130 mL in 1 BOTTLE, DROPPER (44911-0411-1) 30 ml2016-12-302027-04-13NoNoCurrent