Colic

Product NDC: 43857-0369
11-digit product format: 438570369
Labeler code: 43857
Product ID: 43857-0369_5770c5a3-666c-41ae-922f-80f64c2f81b2
Type: HUMAN OTC DRUG
Nonproprietary name: Beta Vulgaris, Carduus Marianus, Lappa Major, Aluminium Metallicum, Arsenicum Album, Chelidonium Majus, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phsophorus
Dosage form: LIQUID
Route: ORAL
Labeler: BioActive Nutritional, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2015-05-21
Substance: ALUMINUM; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BETA VULGARIS WHOLE; CHELIDONIUM MAJUS WHOLE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED
Active strength: 12; 3; 12; 3; 12; 12; 12; 3; 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
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43857-0369-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43857-0369-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43857-0369-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43857-0369-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43857-0369-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43857-0369-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43857-0369-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43857-0369-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43857-0369-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43857-0369-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43857-0369-1	`9bebd1f3094a…`	`5416666fcb17…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BETA VULGARIS WHOLE	12 [hp_X]/mL
MILK THISTLE	3 [hp_X]/mL
ARCTIUM LAPPA ROOT	12 [hp_X]/mL
ALUMINUM	3 [hp_X]/mL
ARSENIC TRIOXIDE	12 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE	12 [hp_X]/mL
GOLDENSEAL	12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE	3 [hp_X]/mL
SODIUM SULFATE	12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED	12 [hp_X]/mL
PHOSPHORUS	12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4G174V5051	Internal UNII lookup
U946SH95EE	Internal UNII lookup
597E9BI3Z3	Internal UNII lookup
CPD4NFA903	Internal UNII lookup
S7V92P67HO	Internal UNII lookup
7E889U5RNN	Internal UNII lookup
ZW3Z11D0JV	Internal UNII lookup
C88X29Y479	Internal UNII lookup
0YPR65R21J	Internal UNII lookup
269XH13919	Internal UNII lookup
27YLU75U4W	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6824636-7098-4ac6-9199-c7fc5c7451df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43857-0369-1	2024-10-17	C162847	48780-1	9d75b9d0-44aa-f424-e053-dadaa90a57ce	DRUG FACTS:
43857-0369-1	2020-01-31	C162847	48780-1	9d75b9d0-44aa-f424-e053-dadaa90a57ce	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43857-0369-1	Colic	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM	ACTIVE INGREDIENT	CPD4NFA903	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ARCTIUM LAPPA ROOT	ACTIVE INGREDIENT	597E9BI3Z3	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
BETA VULGARIS	ACTIVE INGREDIENT	4G174V5051	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
CHELIDONIUM MAJUS	ACTIVE INGREDIENT	7E889U5RNN	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
GOLDENSEAL	ACTIVE INGREDIENT	ZW3Z11D0JV	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE INGREDIENT	C88X29Y479	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
MILK THISTLE	ACTIVE INGREDIENT	U946SH95EE	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
PHOSPHORUS	ACTIVE INGREDIENT	27YLU75U4W	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
SODIUM SULFATE	ACTIVE INGREDIENT	0YPR65R21J	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ALUMINUM	ACTIVE MOIETY	CPD4NFA903	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ARCTIUM LAPPA ROOT	ACTIVE MOIETY	597E9BI3Z3	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
BETA VULGARIS	ACTIVE MOIETY	4G174V5051	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
CHELIDONIUM MAJUS	ACTIVE MOIETY	7E889U5RNN	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
GOLDENSEAL	ACTIVE MOIETY	ZW3Z11D0JV	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE MOIETY	C88X29Y479	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
MILK THISTLE	ACTIVE MOIETY	U946SH95EE	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
PHOSPHORUS	ACTIVE MOIETY	27YLU75U4W	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
SODIUM SULFATE ANHYDROUS	ACTIVE MOIETY	36KCS0R750	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43857-0369	COLIC (BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20241019_a6824636-7098-4ac6-9199-c7fc5c7451df.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colic	BETA VULGARIS, CARDUUS MARIANUS, LAPPA MAJOR, ALUMINIUM METALLICUM, ARSENICUM ALBUM, CHELIDONIUM MAJUS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHSOPHORUS	BioActive Nutritional, Inc.	a6824636-7098-4ac6-9199-c7fc5c7451df	2026-03-11	Warnings	Exact identifier ndc (product): 43857-0369

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CPD4NFA903	ALUMINUM	7429-90-5	ALUMINUM
597E9BI3Z3	ARCTIUM LAPPA ROOT		ARCTIUM LAPPA ROOT
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE
ZW3Z11D0JV	GOLDENSEAL		GOLDENSEAL
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
U946SH95EE	MILK THISTLE	65666-07-1	MILK THISTLE
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
0YPR65R21J	SODIUM SULFATE	7727-73-3	SODIUM SULFATE
269XH13919	STRYCHNOS NUX-VOMICA SEED	8046-97-7	STRYCHNOS NUX-VOMICA SEED

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43857-0369-1	43857036901	30 mL in 1 BOTTLE, DROPPER (43857-0369-1)	30 ml	2015-05-21	No	No	Current