Compre Tox

Product NDC
43965-0001
11-digit product format
439650001
Labeler code
43965
Product ID
43965-0001_fe0c8fbd-5d50-43ff-8ad9-49cae367f1d0
Type
HUMAN OTC DRUG
Nonproprietary name
Eriodictyon Californicum, Hamamelis Virginiana, Nymphaea Odorata, Plantago Major, Xanthoxylum Fraxineum, Xerophyllum Asphodeloides
Dosage form
LIQUID
Route
ORAL
Labeler
Kevin Sullivan Navillus
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-09-28
Marketing end
2026-06-30
Substance
ERIODICTYON CALIFORNICUM LEAF; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; ZANTHOXYLUM AMERICANUM BARK
Active strength
3; 3; 3; 3; 3; 3; 3; 3 [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
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

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 productproduct43965-0001DDiscontinued by firm2026-08-10
excluded packagepackage43965-000143965-0001-1DDiscontinued by firm2026-08-10

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43965-0001-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43965-0001-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43965-0001-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43965-0001-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43965-0001-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43965-0001-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43965-0001-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43965-0001-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43965-0001-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43965-0001-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43965-0001-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43965-0001-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43965-0001-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43965-0001-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43965-0001-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43965-0001-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43965-0001-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43965-0001-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43965-0001-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43965-0001-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43965-0001-19bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43965-0001-12020-01-31C16284748780-19d75b9d0-3b23-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43965-0001-1Compre Tox60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERIODICTYON CALIFORNICUM LEAFACTIVE INGREDIENT2Y7TIQ135HCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
GINGERACTIVE INGREDIENTC5529G5JPQCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJSCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
NYMPHAEA ODORATA ROOTACTIVE INGREDIENT69RAZ4C432COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
XEROPHYLLUM ASPHODELOIDESACTIVE INGREDIENT9I4XB1GP2BCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
YUCCA FILAMENTOSAACTIVE INGREDIENTT6VR38UJ9ICOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
ZANTHOXYLUM AMERICANUM BARKACTIVE INGREDIENTA4KL1HMZ7TCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
ERIODICTYON CALIFORNICUM LEAFACTIVE MOIETY2Y7TIQ135HCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
GINGERACTIVE MOIETYC5529G5JPQCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJSCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
NYMPHAEA ODORATA ROOTACTIVE MOIETY69RAZ4C432COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
XEROPHYLLUM ASPHODELOIDESACTIVE MOIETY9I4XB1GP2BCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
YUCCA FILAMENTOSAACTIVE MOIETYT6VR38UJ9ICOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
ZANTHOXYLUM AMERICANUM BARKACTIVE MOIETYA4KL1HMZ7TCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3
WATERINACTIVE INGREDIENT059QF0KO0RCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43965-0001COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES) LIQUID [KEVIN SULLIVAN NAVILLUS]3Current NDC, Legacy NDC, 1 package rows20121024_7123bb9f-3e41-4573-aa34-24a8bdf07983.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43965-0001-14396500010160 mL in 1 BOTTLE, DROPPER (43965-0001-1) 60 ml2012-09-282026-06-30NoNoHistorical