FDA.reportPublic FDA data

ASP

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:27:51

Label at a glance#

ProductASP
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, HANDROANTHUS IMPETIGINOSUS BARK, GOLDENSEAL, SUS SCROFA ADRENAL GLAND, SUS SCROFA THYMUS, THYROID, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, ANAMIRTA COCCULUS SEED, COLCHICUM AUTUMNALE BULB, LEDUM PALUSTRE TWIG, MERCURIC CYANIDE, SODIUM SULFATE, PULSATILLA PRATENSIS WHOLE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, AFLATOXIN B1
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

Echinacea (Angustifolia) 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Arsenicum Album 12X, Bryonia (Alba) 12X, Cocculus Indicus 12X, Colchicum Autumnale 12X, Ledum Palustre 12X, Mercurius Cyanatus 12X, Natrum Sulphuricum 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Silicea 12X, Aflatoxin (B1) 30X, 60X, 200X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms of cough with expectoration & dyspepsia, ill effects of melons, water & dried fruits, thick yellow ropy mucous secretions.

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 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 symptoms of cough with expectoration & dyspepsia, ill effects of melons, water & dried fruits, thick yellow ropy mucous secretions.

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

ASP

HOMEOPATHIC

1 FL OZ (30 ml)

ASPASP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0547-12024-08-28C16284748780-1d6a99b39-a17a-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0547-12022-01-28C16284748780-1d6a99b39-a17a-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0547-1ASP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0547ASP (ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240829_66fe5457-fe15-4e33-b47e-2c0dc9b171f6.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-054743857-0547-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
HANDROANTHUS IMPETIGINOSUS BARK6GLA1946WXACTIB
GOLDENSEALZW3Z11D0JVACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA THYMUS7B69B0BD62ACTIB
THYROID6RV024OAUQACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
MERCURIC CYANIDERWG7BD1032ACTIB
SODIUM SULFATE0YPR65R21JACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
AFLATOXIN B19N2N2Y55MHACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
ASPECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1)BioActive Nutritional, Inc.66fe5457-fe15-4e33-b47e-2c0dc9b171f62024-08-28WarningsExact identifier
ndc (package): 43857-0547-1
ndc (product): 43857-0547
ndc11 (package): 43857054701
spl id: 73413192-c4d1-4697-a1cc-363ed2a81b0b
spl set id: 66fe5457-fe15-4e33-b47e-2c0dc9b171f6

Reported adverse events (FAERS/openFDA)#

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