Food Additives
- Product NDC
- 43857-0168
- 11-digit product format
- 438570168
- Labeler code
- 43857
- Product ID
- 43857-0168_4af75847-5944-45b7-95d6-efa3369c29ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Berberis Vulgaris, Chelidonium Majus, Trifolium Pratense, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Rhamnus Purshiana, Stillingia Sylvatica, Xanthoxylum Fraxineum, Arsenicum Album, Belladonna, Lycopodium Clavatum, Natrum Sulphuricum, Phosphoricum Acidum
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2013-05-16
- Substance
- BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; TRIFOLIUM PRATENSE FLOWER; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; ZANTHOXYLUM AMERICANUM BARK; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORIC ACID
- Active strength
- 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 12; 12; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Food Additives
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BERBERIS VULGARIS ROOT BARK | 3 [hp_X]/mL |
| CHELIDONIUM MAJUS | 3 [hp_X]/mL |
| TRIFOLIUM PRATENSE FLOWER | 3 [hp_X]/mL |
| GLYCYRRHIZA GLABRA | 4 [hp_X]/mL |
| ARCTIUM LAPPA ROOT | 4 [hp_X]/mL |
| PHYTOLACCA AMERICANA ROOT | 4 [hp_X]/mL |
| FRANGULA ALNUS BARK | 4 [hp_X]/mL |
| FRANGULA PURSHIANA BARK | 4 [hp_X]/mL |
| STILLINGIA SYLVATICA ROOT | 4 [hp_X]/mL |
| ZANTHOXYLUM AMERICANUM BARK | 4 [hp_X]/mL |
| ARSENIC TRIOXIDE | 12 [hp_X]/mL |
| ATROPA BELLADONNA WHOLE | 12 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 12 [hp_X]/mL |
| SODIUM SULFATE | 12 [hp_X]/mL |
| PHOSPHORIC ACID | 12 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1TH8Q20J0U | Internal UNII lookup |
| 7E889U5RNN | Internal UNII lookup |
| 4JS0838828 | Internal UNII lookup |
| 2788Z9758H | Internal UNII lookup |
| 597E9BI3Z3 | Internal UNII lookup |
| 11E6VI8VEG | Internal UNII lookup |
| S2D77IH61R | Internal UNII lookup |
| 4VBP01X99F | Internal UNII lookup |
| QBR70R4FBK | Internal UNII lookup |
| A4KL1HMZ7T | Internal UNII lookup |
| S7V92P67HO | Internal UNII lookup |
| DSV74G1P2J | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| 0YPR65R21J | Internal UNII lookup |
| E4GA8884NN | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bf27d457-12e1-4ab6-b132-1b65cde0ed93 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0168-1 | Food Additives | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43857-0168 | FOOD ADDITIVES (BERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20160929_bf27d457-12e1-4ab6-b132-1b65cde0ed93.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 |
|---|---|---|---|---|---|---|
| Food Additives | BERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM | BioActive Nutritional, Inc. | bf27d457-12e1-4ab6-b132-1b65cde0ed93 | 2016-09-28 | Warnings | 43857-0168 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43857-0168-1 | 43857016801 | 30 mL in 1 BOTTLE, DROPPER (43857-0168-1) | 30 ml | 2016-09-28 | 0000-00-00 | No | No | Current |