FDA.reportPublic FDA data

Colic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:56

Label at a glance#

ProductColic
Active ingredientBETA VULGARIS WHOLE, MILK THISTLE, ARCTIUM LAPPA ROOT, ALUMINUM, ARSENIC TRIOXIDE, CHELIDONIUM MAJUS WHOLE, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Indications and uses

For temporary relief of bloating and fullness of the abdomen; flatulence; painful menses, abdominal cramping, and colic.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aluminium Metallicum 12X, Arsenicum Album 12X, Beta Vulgaris 3X, Carduus Marianus 3X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lappa Major 3X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X.

PURPOSE:

OTC - PURPOSE SECTION

Aluminium Metallicum – stomach inflammation,** Arsenicum Album - nausea,** Beta Vulgaris – mucus congestion,** Carduus Marianus – upset stomach,** Chelidonium Majus - gas,** Hydrastis Canadensis - fever,** Lappa Major - cough,** Lycopodium Clavatum - bloating,** Natrum Sulphuricum – abdominal pain,** Nux Vomica – stomach cramps,** Phosphorus – stomach inflammation**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of bloating and fullness of the abdomen; flatulence; painful menses, abdominal cramping, and colic.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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

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 or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional 

COLIC

Homeopathic

1 fl. oz. (30 mL)

COLICCOLIC

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341350GTIN-13: 0210184341350
EAN-13: 0210184341350
GTIN-12: 210184341350
UPC-A: 210184341350
GTIN storage (14 digits): 00210184341350		BANI0283 Colic 11-11-25.jpg

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
43857-0369-12024-10-17C16284748780-19d75b9d0-44aa-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0369-12020-01-31C16284748780-19d75b9d0-44aa-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0369-1Colic30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUMACTIVE INGREDIENTCPD4NFA9031
ARCTIUM LAPPA ROOTACTIVE INGREDIENT597E9BI3Z31
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BETA VULGARISACTIVE INGREDIENT4G174V50511
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MILK THISTLEACTIVE INGREDIENTU946SH95EE1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
ALUMINUMACTIVE MOIETYCPD4NFA9031
ARCTIUM LAPPA ROOTACTIVE MOIETY597E9BI3Z31
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BETA VULGARISACTIVE MOIETY4G174V50511
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MILK THISTLEACTIVE MOIETYU946SH95EE1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-036943857-0369-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA VULGARIS WHOLE4G174V5051ACTIB
MILK THISTLEU946SH95EEACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
ALUMINUMCPD4NFA903ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
GOLDENSEALZW3Z11D0JVACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
ColicBETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUSBioActive Nutritional, Inc.a6824636-7098-4ac6-9199-c7fc5c7451df2026-03-11WarningsExact identifier
ndc (package): 43857-0369-1
ndc (product): 43857-0369
ndc11 (package): 43857036901
spl id: 5770c5a3-666c-41ae-922f-80f64c2f81b2
spl set id: a6824636-7098-4ac6-9199-c7fc5c7451df

Reported adverse events (FAERS/openFDA)#

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