Traumatone

Product NDC
57520-0563
Requested package NDC
57520-0563-1
11-digit product format
575200563
Labeler code
57520
Product ID
57520-0563_dd845fdf-efdc-44da-a684-8d6c96f2e8e3
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula officinalis, Symphytum officinale, Staphysagria, Rhus Toxicodendron, Ruta Graveolens, Bellis perennis,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-07-22
Marketing end
2022-09-09
Substance
ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF
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; [hp_X]/mL
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 packagepackage57520-056357520-0563-1DDiscontinued by firm2026-08-11

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 · 17 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…
2022-04-04 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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0563-12022-04-06C16284748780-19d75b9d0-3166-f424-e053-dadaa90a57ceTraumatone
57520-0563-12020-01-31C16284748780-19d75b9d0-3166-f424-e053-dadaa90a57ceTraumatone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UYTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNBTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587STRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
STRONTIUM CARBONATEACTIVE INGREDIENT41YPU4MMCATRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ATRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
BELLIS PERENNISACTIVE MOIETY2HU33I03UYTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNBTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587STRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
STRONTIUM CATIONACTIVE MOIETY37077S2C93TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ATRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RTRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, STAPHYSAGRIA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, BELLIS PERENNIS,) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0563-15752005630130 mL in 1 BOTTLE, DROPPER (57520-0563-1) 30 ml2010-07-222022-09-09NoNoCurrent