ApoPlex

Product NDC
57955-0067
11-digit product format
579550067
Labeler code
57955
Product ID
57955-0067_0b4748b2-675e-46ea-8c04-be5109e0f1cb
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Belladonna, Calendula officinalis, Causticum, Cocculus indicus, Gloninum, Lachesis mutus, Plumbum metallicum
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-07-23
Marketing end
0000-00-00
Substance
ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; LACHESIS MUTA VENOM; LEAD
Active strength
10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57955-0067DDiscontinued by firm2026-10-05
excluded packagepackage57955-006757955-0067-2DDiscontinued 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57955-0067-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57955-0067-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57955-0067-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57955-0067-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57955-0067-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57955-0067-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57955-0067-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57955-0067-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57955-0067-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57955-0067-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57955-0067-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57955-0067-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57955-0067-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57955-0067-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57955-0067-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57955-0067-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57955-0067-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57955-0067-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57955-0067-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57955-0067-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57955-0067-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57955-0067-2EExcluded 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0067-22020-01-31C16284748780-19d75b9d0-876d-f424-e053-dadaa90a57ceApoPlex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0067-2ApoPlex59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28UAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFUAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07IAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
LEADACTIVE INGREDIENT2P299V784PAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3APOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28UAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
CAUSTICUMACTIVE MOIETYDD5FO1WKFUAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07IAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
LEADACTIVE MOIETY2P299V784PAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
NITROGLYCERINACTIVE MOIETYG59M7S0WS3APOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4APOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RAPOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0067APOPLEX (ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CAUSTICUM, COCCULUS INDICUS, GLONINUM, LACHESIS MUTUS, PLUMBUM METALLICUM) LIQUID [KING BIO INC.]2Legacy NDC, 1 package rows20150307_b9ed0541-6bf6-4bd2-96ea-1fa90bdada0c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57955-0067-25795500670259 mL in 1 BOTTLE, SPRAY59 mlHistorical