Bone Repair

Product NDC
57520-0375
Requested package NDC
57520-0375-1
11-digit product format
575200375
Labeler code
57520
Product ID
57520-0375_652ad1c0-caa0-4cdb-a6ed-ad2530e56827
Type
HUMAN OTC DRUG
Nonproprietary name
Calcarea carbonica, Calcarea Fluorica, Calcarea phosphorica, Hekla lava, Hydrofluoricum acidum, Magnesia phosphorica Rhus toxicodendron, Ruta graveolens, Silicea, Symphytum officinale
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-04-30
Marketing end
2022-08-04
Substance
CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE
Active strength
30 [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], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage57520-037557520-0375-1DDiscontinued by firm2026-10-05

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 · 18 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…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded 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
57520-0375-12022-06-04C16284748780-19d75b9d0-5cbf-f424-e053-dadaa90a57ceBone Repair HP
57520-0375-12020-01-31C16284748780-19d75b9d0-5cbf-f424-e053-dadaa90a57ceBone Repair HP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKIBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
HEKLA LAVAACTIVE INGREDIENTC21158IIRKBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3QBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6IBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4BONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ABONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z28BONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKIBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
HEKLA LAVAACTIVE MOIETYC21158IIRKBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
HYDROFLUORIC ACIDACTIVE MOIETYRGL5YE86CZBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838BONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6IBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4BONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ABONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RBONE REPAIR HP (CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SYMPHYTUM OFFICINALE) LIQUID [APOTHECA COMPANY]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0375-15752003750130 mL in 1 BOTTLE, DROPPER (57520-0375-1) 30 ml2010-04-302022-08-04NoNoCurrent