Universaltox

Product NDC
43857-0534
11-digit product format
438570534
Labeler code
43857
Product ID
43857-0534_029b94bd-3241-4a9b-80f8-29996a8905a8
Type
HUMAN OTC DRUG
Nonproprietary name
Alfalfa, Avena Sativa, Fucus Vesiculosus, Hordeum Vulgare, Nasturtium Aquaticum, Raphanus Sativus, Triticum Aestivum, Iodium, Ubidecarenonum, Glandula Suprarenalis Suis, Hepar Suis, Manganese Gluconate, Oryza Sativa, Thyroidinum (Suis), Calcarea Carbonica, Natrum Muriaticum, Pulsatilla (Pratensis), Rhus Tox, Cortisone Aceticum
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-03
Substance
ALFALFA; AVENA SATIVA FLOWERING TOP; BROWN RICE; CORTISONE ACETATE; DAIKON; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; IODINE; MANGANESE GLUCONATE; NASTURTIUM OFFICINALE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; PULSATILLA PRATENSIS WHOLE; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THYROID; TOXICODENDRON PUBESCENS LEAF; TRITICUM AESTIVUM WHOLE; UBIDECARENONE
Active strength
3; 3; 8; 30; 4; 4; 4; 6; 8; 4; 12; 8; 12; 12; 8; 8; 12; 4; 6 [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; [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], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Magnetic Resonance Contrast Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0534-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0534-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0534-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0534-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0534-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43857-0534-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43857-0534-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43857-0534-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43857-0534-18dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

Finished product
Yes
Brand name base
Universaltox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFALFA3 [hp_X]/mL
AVENA SATIVA FLOWERING TOP3 [hp_X]/mL
FUCUS VESICULOSUS8 [hp_X]/mL
HORDEUM VULGARE TOP30 [hp_X]/mL
NASTURTIUM OFFICINALE4 [hp_X]/mL
DAIKON4 [hp_X]/mL
TRITICUM AESTIVUM WHOLE4 [hp_X]/mL
IODINE6 [hp_X]/mL
UBIDECARENONE8 [hp_X]/mL
SUS SCROFA ADRENAL GLAND4 [hp_X]/mL
PORK LIVER12 [hp_X]/mL
MANGANESE GLUCONATE8 [hp_X]/mL
BROWN RICE12 [hp_X]/mL
THYROID12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]/mL
SODIUM CHLORIDE8 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF4 [hp_X]/mL
CORTISONE ACETATE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DJO934BRBDInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
535G2ABX9MInternal UNII lookup
86507VZR9KInternal UNII lookup
YH89GMV676Internal UNII lookup
86R5J6D01DInternal UNII lookup
3C3Y389JBUInternal UNII lookup
9679TC07X4Internal UNII lookup
EJ27X76M46Internal UNII lookup
398IYQ16YVInternal UNII lookup
6EC706HI7FInternal UNII lookup
9YY2F980SVInternal UNII lookup
659G217HPGInternal UNII lookup
6RV024OAUQInternal UNII lookup
2E32821G6IInternal UNII lookup
451W47IQ8XInternal UNII lookup
8E272251DIInternal UNII lookup
6IO182RP7AInternal UNII lookup
883WKN7W8XInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad454e8a-4f78-4aac-90d9-a3f26a6fbe42Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0534-12024-10-18C16284748780-1ba0f9c33-293e-a910-e053-dadaa90a0b85DRUG FACT:
43857-0534-12021-01-29C16284748780-1ba0f9c33-293e-a910-e053-dadaa90a0b85DRUG FACT:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0534-1Universaltox30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0534UNIVERSALTOX (ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241020_ad454e8a-4f78-4aac-90d9-a3f26a6fbe42.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
ndc (product): 43857-0534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0534-14385705340130 mL in 1 BOTTLE, DROPPER (43857-0534-1) 30 ml2019-10-03NoNoCurrent