Osteopar

Product NDC
44911-0367
Requested package NDC
44911-0367-1
11-digit product format
449110367
Labeler code
44911
Product ID
44911-0367_e4edf638-e46c-433b-bb5a-d664dd45c560
Type
HUMAN OTC DRUG
Nonproprietary name
Equisetum Hyemale, Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Medulla Ossis Suis, Ossa Sepia, Silicea, Hekla Lava
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-06-16
Marketing end
2027-09-13
Substance
CALCIUM FLUORIDE; COMFREY ROOT; EQUISETUM HYEMALE WHOLE; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA ESCULENTA BONE; SILICON DIOXIDE; SUS SCROFA BONE MARROW; TRIBASIC CALCIUM PHOSPHATE
Active strength
12; 6; 3; 15; 12; 12; 12; 12; 12 [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
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-036744911-0367-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Osteopar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EQUISETUM HYEMALE WHOLE12 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]/mL
CALCIUM FLUORIDE15 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL
SUS SCROFA BONE MARROW12 [hp_X]/mL
SEPIA ESCULENTA BONE12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
HEKLA LAVA12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59677RXH25Internal UNII lookup
M9VVZ08EKQInternal UNII lookup
2E32821G6IInternal UNII lookup
O3B55K4YKIInternal UNII lookup
91D9GV0Z28Internal UNII lookup
VP2CN2G7Y8Internal UNII lookup
M6XU683549Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
C21158IIRKInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
daf83dbf-bbf4-49e2-ade1-1d86f3e52675Available on FDA.report

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
44911-0367-12024-05-09C16284748780-1f386c649-d83e-0266-e053-dadaa90a7c1aDrug Facts:
44911-0367-12023-01-30C16284748780-1f386c649-d83e-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0367-1Osteopar30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0367OSTEOPAR (EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVA) LIQUID [ENERGIQUE, INC.]5Current NDC, Legacy NDC, 1 package rows20240510_daf83dbf-bbf4-49e2-ade1-1d86f3e52675.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
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVAEnergique, Inc.daf83dbf-bbf4-49e2-ade1-1d86f3e526752024-05-09WarningsExact identifier
ndc (package): 44911-0367-1
ndc (product): 44911-0367
ndc11 (package): 44911036701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0367-14491103670130 mL in 1 BOTTLE, DROPPER (44911-0367-1) 30 ml2016-06-162027-09-13NoNoCurrent