FDA.reportPublic FDA data

Dairy Antigens

Manufacturer
BioActive Nutritional | Apotheca Company
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:01

Label at a glance#

ProductDairy Antigens
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, SKIM MILK, SEPIA OFFICINALIS JUICE, SULFUR, WHEY, CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED, CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED, CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED, CASEIN, LACTOCOCCUS LACTIS CULTURED, GOAT MILK, COW MILK, CASEIN, EMMENTAL CULTURED
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of allergies due to milk products.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of allergies due to milk products.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

DAIRY ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

Dairy AntigensDairy Antigens

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0554-12024-08-28C16284748780-1d6a99b39-a302-a426-e053-dadaa90af4c2DRUG FACTS
43857-0554-12024-08-28C16284748780-1d6a99b39-a302-a426-e053-dadaa90af4c2DRUG FACTS
43857-0554-12022-01-28C16284748780-1d6a99b39-a302-a426-e053-dadaa90af4c2DRUG FACTS
43857-0554-12022-01-28C16284748780-1d6a99b39-a302-a426-e053-dadaa90af4c2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0554-1Dairy Antigens30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-055443857-0554-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
SKIM MILK6A001Y4M5AACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
WHEY8617Z5FMF6ACTIB
CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGEDIYI0G2057SACTIB
CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGEDG44KTI7KISACTIB
CASEIN, LACTOCOCCUS LACTIS CULTURED, AGEDCJP9NL7JSJACTIB
CASEIN, LACTOCOCCUS LACTIS CULTURED489F5JNV5BACTIB
GOAT MILKXE5K5I4RP7ACTIB
COW MILK917J3173FTACTIB
CASEIN, EMMENTAL CULTURED13811K7P3XACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-08-28full-release2026-06-01 02:27:51

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
Dairy AntigensCALCAREA CARBONICA, LAC DEFLORATUM, SEPIA, SULPHUR, AMERICAN CHEESE, CHEESE (STILTON), CHEESE (CAMEMBERT), CHEDDAR CHEESE, COTTAGE CHEESE, LAC CAPRINUM, LAC VACCINUM, SWISS CHEESEBioActive Nutritional950cab64-990d-4639-8576-e7e88b2003492025-10-06WarningsExact identifier
ndc (package): 43857-0554-1
ndc (product): 43857-0554
ndc11 (package): 43857055401
spl id: 1060f969-e217-4b35-be0a-0d7779794270
spl set id: 950cab64-990d-4639-8576-e7e88b200349

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.