Bactestat

Product NDC
57520-0501
Requested package NDC
57520-0501-1
11-digit product format
575200501
Labeler code
57520
Product ID
57520-0501_cf14f3ab-0bcd-4fbe-bd3b-9ae9cd70614a
Type
HUMAN OTC DRUG
Nonproprietary name
Baptisia tinctoria, Echinacea, Phytolacca decandra
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-06-14
Marketing end
2022-09-18
Substance
ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT
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
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 packagepackage57520-050157520-0501-1DDiscontinued 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
57520-0501-12022-04-19C16284748780-19d75b9d0-dab9-f424-e053-dadaa90a57ceBactestat
57520-0501-12020-01-31C16284748780-19d75b9d0-dab9-f424-e053-dadaa90a57ceBactestat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WUBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ECHINACEAACTIVE INGREDIENT4N9P6CC1DXBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
FERRUM PHOSPHORICUMACTIVE INGREDIENT91GQH8I5F7BACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07IBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HOBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WUBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ECHINACEAACTIVE MOIETY4N9P6CC1DXBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
FERRUM PHOSPHORICUMACTIVE MOIETY91GQH8I5F7BACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07IBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RBACTESTAT (BAPTISIA TINCTORIA, ECHINACEA, PHYTOLACCA DECANDRA) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0501-15752005010130 mL in 1 BOTTLE, DROPPER (57520-0501-1) 30 ml2010-06-142022-09-18NoNoCurrent