Colic
- Product NDC
- 43857-0369
- Requested package NDC
- 43857-0369-1
- 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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 9bebd1f3094a… | 5416666fcb17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Colic
- Listing expiration
- 2027-12-31
Active Ingredients#
| 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#
| 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#
| Identifier | FDA.report destination |
|---|---|
| a6824636-7098-4ac6-9199-c7fc5c7451df | Available on FDA.report |
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 |
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.
| 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 | 43857-0369-1 43857-0369 43857036901 |
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 | Current |