Neobryxol Ultra

Product NDC
45984-0003
11-digit product format
459840003
Labeler code
45984
Product ID
45984-0003_f4210529-a4e4-44ab-abd7-9421921e4c2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Asterias rubens, Bryonia alba, Conium maculatum Galium aparine, Hoang-nan, Lachesis, Ledum palustre, Nux Vomica, Ova tosta and Viscum album.
Dosage form
LIQUID
Route
ORAL
Labeler
Bryomed Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-04-04
Marketing end
0000-00-00
Substance
ASTERIAS RUBENS; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; STRYCHNOS WALLICHIANA BARK; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; STRYCHNOS NUX-VOMICA SEED; EGG SHELL, COOKED; VISCUM ALBUM WHOLE
Active strength
10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
Pharmacologic classes
Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]
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 productproduct45984-0003IInactivated by FDA2026-10-05
excluded packagepackage45984-000345984-0003-1IInactivated by FDA2026-10-05

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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1IInactivated 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 packagepackage45984-0003-1EExcluded 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
45984-0003-12020-01-31C16284748780-19d75b9d0-dc72-f424-e053-dadaa90a57ceNeobryxol Ultra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45984-0003-1Neobryxol Ultra60 mL in 1 BOTTLE, DROPPERLIQUID605

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASTERIAS RUBENSACTIVE INGREDIENTA7FYY9Q742NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF371NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
EGG SHELL, COOKEDACTIVE INGREDIENT24HBF856C8NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
GALIUM APARINEACTIVE INGREDIENTZ4B6561488NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07INEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
STRYCHNOS WALLICHIANA BARKACTIVE INGREDIENTOQ16ZEE7O7NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
VISCUM ALBUM WHOLEACTIVE INGREDIENTE6839Q6DO1NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
ASTERIAS RUBENSACTIVE MOIETYA7FYY9Q742NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF371NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
EGG SHELL, COOKEDACTIVE MOIETY24HBF856C8NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
GALIUM APARINEACTIVE MOIETYZ4B6561488NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07INEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
STRYCHNOS WALLICHIANA BARKACTIVE MOIETYOQ16ZEE7O7NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
VISCUM ALBUM WHOLEACTIVE MOIETYE6839Q6DO1NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RNEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45984-0003NEOBRYXOL ULTRA (ASTERIAS RUBENS, BRYONIA ALBA, CONIUM MACULATUM GALIUM APARINE, HOANG-NAN, LACHESIS, LEDUM PALUSTRE, NUX VOMICA, OVA TOSTA AND VISCUM ALBUM.) LIQUID [BRYOMED INC.]5Legacy NDC, 1 package rows20120413_9f6bb5bf-0846-4a3d-9aee-97e6d50cc41a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
45984-0003-14598400030160 mL in 1 BOTTLE, DROPPER60 mlHistorical