Osteotone

Product NDC
44911-0447
Requested package NDC
44911-0447-1
11-digit product format
449110447
Labeler code
44911
Product ID
44911-0447_8534e79c-f25d-44f8-9418-a8c0e2547864
Type
HUMAN OTC DRUG
Nonproprietary name
Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Causticum, Hekla Lava, Pulsatilla (Pratensis), Rhus Tox, Silicea, Strontium Carbonicum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-11-29
Marketing end
0000-00-00
Substance
CALCIUM FLUORIDE; CAUSTICUM; COMFREY ROOT; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE
Active strength
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; [hp_X]/mL
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 packagepackage44911-044744911-0447-1DDiscontinued by firm2026-09-14

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0447-12022-03-14C16284748780-1ba0f9c33-59f7-a910-e053-dadaa90a0b85Drug Facts:
44911-0447-12021-01-29C16284748780-1ba0f9c33-59f7-a910-e053-dadaa90a0b85Drug Facts:

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0447-14491104470130 mL in 1 BOTTLE, DROPPER (44911-0447-1) 30 ml2017-11-290000-00-00NoNoCurrent