FDA.reportPublic FDA data

Allergen

Product NDC
43857-0626
11-digit product format
438570626
Labeler code
43857
Product ID
43857-0626_703834c0-4323-4295-b9e6-6c539075de0c
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant (Solanum Melongena), Rape Seed Oil, Linum Usitatissimum, Sesame Seed, Cheese (Stilton), Lac Vaccinum, Beef, Lamb, Pork, Chicken, Egg (Whole), Phaseolus, Allium Cepa, Apple, Wheat, Banana, Strawberry, Cod (Gadus Morhua), Tuna (Thunnus Thynnus),
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-06-15
Substance
APPLE; ARSENIC TRIOXIDE; ATLANTIC COD; ATLANTIC SALMON; BANANA; BEEF; BITTER ALMOND; BLACK WALNUT; BOS TAURUS ADRENAL GLAND; BRAZIL NUT; CANOLA OIL; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASHEW; CHICKEN; COCONUT; CORTISONE ACETATE; COW MILK; CRANGON SHRIMP; EDIBLE ROCK CRAB; EGG; EGGPLANT; ENGLISH WALNUT; FLAX SEED; FRAGARIA VESCA FRUIT; GREEN PEPPERCORN; HEPARIN, BOVINE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE (BOVINE); INTERLEUKIN-1 .BETA. HUMAN; KIDNEY BEAN; LAMB; LYCOPODIUM CLAVATUM SPORE; NORTHERN BLUEFIN TUNA; ONION; ORANGE; PACIFIC OYSTER; PEANUT; PECAN; PHOSPHORUS; PORK; POTASSIUM GLUCONATE; SEROTONIN HYDROCHLORIDE; SESAME SEED; SOLANUM TUBEROSUM WHOLE; STRYCHNOS NUX-VOMICA SEED; TOMATO; WHEAT
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 30; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 30; 12; 12; 12; 12; 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; [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; [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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Endoglycosidase [EPC], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Glycoside Hydrolases [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Rel...
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0626-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0626-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0626-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0626-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Allergen
Brand name suffix
I
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM GLUCONATE12 [hp_X]/mL
BOS TAURUS ADRENAL GLAND12 [hp_X]/mL
HEPARIN, BOVINE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PEANUT12 [hp_X]/mL
BLACK WALNUT8 [hp_X]/mL
ENGLISH WALNUT12 [hp_X]/mL
BITTER ALMOND12 [hp_X]/mL
CASHEW12 [hp_X]/mL
COCONUT12 [hp_X]/mL
PECAN12 [hp_X]/mL
BRAZIL NUT12 [hp_X]/mL
TOMATO30 [hp_X]/mL
SOLANUM TUBEROSUM WHOLE12 [hp_X]/mL
GREEN PEPPERCORN12 [hp_X]/mL
EGGPLANT12 [hp_X]/mL
CANOLA OIL12 [hp_X]/mL
FLAX SEED12 [hp_X]/mL
SESAME SEED12 [hp_X]/mL
CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED12 [hp_X]/mL
COW MILK12 [hp_X]/mL
BEEF12 [hp_X]/mL
LAMB8 [hp_X]/mL
PORK30 [hp_X]/mL
CHICKEN30 [hp_X]/mL
EGG30 [hp_X]/mL
KIDNEY BEAN12 [hp_X]/mL
ONION12 [hp_X]/mL
APPLE12 [hp_X]/mL
WHEAT12 [hp_X]/mL
BANANA12 [hp_X]/mL
FRAGARIA VESCA FRUIT12 [hp_X]/mL
ORANGE12 [hp_X]/mL
ATLANTIC COD12 [hp_X]/mL
NORTHERN BLUEFIN TUNA12 [hp_X]/mL
ATLANTIC SALMON12 [hp_X]/mL
EDIBLE ROCK CRAB12 [hp_X]/mL
PACIFIC OYSTER6 [hp_X]/mL
CRANGON SHRIMP30 [hp_X]/mL
CORTISONE ACETATE12 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
HYALURONIDASE (BOVINE)12 [hp_X]/mL
INTERLEUKIN-1 .BETA. HUMAN12 [hp_X]/mL
SEROTONIN HYDROCHLORIDE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 3 · 47 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12H3K5QKN9Internal UNII lookup
M2776SWB29Internal UNII lookup
P776JQ4R2FInternal UNII lookup
S7V92P67HOInternal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
QE1QX6B99RInternal UNII lookup
02WM57RXZJInternal UNII lookup
1V3SHR7QB7Internal UNII lookup
O65SFW8R9AInternal UNII lookup
3H5U5CX7KOInternal UNII lookup
3RT3536DHYInternal UNII lookup
F14P91GB5FInternal UNII lookup
XKR79OET1KInternal UNII lookup
Z4KHF2C175Internal UNII lookup
2A8I57T4MXInternal UNII lookup
6G53L8ESRKInternal UNII lookup
W5K7RAS4VKInternal UNII lookup
331KBJ17RKInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25e10444-a2cc-4f74-bf38-9852c273e5caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct 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
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
43857-0626-12024-10-02C16284748780-11030e365-5f18-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0626-12024-01-30C16284748780-11030e365-5f18-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0626-1AllergenI30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0626ALLERGEN I (POTASSIUM GLUCONATE, GLANDULA SUPRARENALIS BOVINE, HEPAR BOVINE, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT (SOLANUM MELONGENA), RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG (WHOLE), PHASEOLUS, ALLIUM CEPA, APPLE, WHEAT, BANANA, STRAWBERRY, COD (GADUS MORHUA), TUNA (THUNNUS THYNNUS),) LIQUID [BIOACTIVE NUTRITIONAL]2Current NDC, Legacy NDC, 1 package rows20241004_25e10444-a2cc-4f74-bf38-9852c273e5ca.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
Allergen IPOTASSIUM GLUCONATE, GLANDULA SUPRARENALIS BOVINE, HEPAR BOVINE, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT (SOLANUM MELONGENA), RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG (WHOLE), PHASEOLUS, ALLIUM CEPA, APPLE, WHEAT, BANANA, STRAWBERRY, COD (GADUS MORHUA), TUNA (THUNNUS THYNNUS),BioActive Nutritional25e10444-a2cc-4f74-bf38-9852c273e5ca2026-03-06WarningsExact identifier
ndc (product): 43857-0626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0626-14385706260130 mL in 1 BOTTLE, DROPPER (43857-0626-1) 30 ml2022-06-150000-00-00NoNoCurrent