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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Colic
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALUMINUM | 12 [hp_X]/mL |
| ARCTIUM LAPPA ROOT | 3 [hp_X]/mL |
| ARSENIC TRIOXIDE | 12 [hp_X]/mL |
| BETA VULGARIS WHOLE | 3 [hp_X]/mL |
| CHELIDONIUM MAJUS WHOLE | 12 [hp_X]/mL |
| GOLDENSEAL | 12 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 12 [hp_X]/mL |
| MILK THISTLE | 3 [hp_X]/mL |
| PHOSPHORUS | 12 [hp_X]/mL |
| SODIUM SULFATE | 12 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 12 [hp_X]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | CPD4NFA903, 597E9BI3Z3, S7V92P67HO, 4G174V5051, 7E889U5RNN, ZW3Z11D0JV, C88X29Y479, U946SH95EE, 27YLU75U4W, 0YPR65R21J, 269XH13919 |
DailyMed Product Concepts#
| 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 | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0369-1 | Colic | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| 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 |
Packages#
| 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 | Historical |