B04
- Product NDC
- 63479-0204
- Requested package NDC
- 63479-0204-1
- 11-digit product format
- 634790204
- Labeler code
- 63479
- Product ID
- 63479-0204_0e76a879-b2c8-dcc6-e063-6294a90ac60e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM
- Dosage form
- SOLUTION/ DROPS
- Route
- SUBLINGUAL
- Labeler
- Apex Energetics Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 1994-12-15
- Substance
- PANCRELIPASE; PEPSIN; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; STAR ANISE; POTASSIUM CARBONATE; ACTIVATED CHARCOAL; BERBERIS VULGARIS ROOT BARK; CAJUPUT OIL; CARBO ANIMALIS; BOS TAURUS BILE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; GENTIANA LUTEA ROOT; INDOLE; SKATOLE; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; RADISH; ALFALFA; ANTIMONY TRISULFIDE
- Active strength
- 10; 4; 1; 2; 1; 10; 20; 4; 3; 15; 4; 9; 8; 30; 1; 12; 12; 1; 1; 8; 1; 15 [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; [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], Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- B04
- Brand name suffix
- DIGESTION
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PANCRELIPASE | 10 [hp_X]/mL |
| PEPSIN | 4 [hp_X]/mL |
| FRANGULA PURSHIANA BARK | 1 [hp_X]/mL |
| GLYCYRRHIZA GLABRA | 2 [hp_X]/mL |
| STAR ANISE | 1 [hp_X]/mL |
| POTASSIUM CARBONATE | 10 [hp_X]/mL |
| ACTIVATED CHARCOAL | 20 [hp_X]/mL |
| BERBERIS VULGARIS ROOT BARK | 4 [hp_X]/mL |
| CAJUPUT OIL | 3 [hp_X]/mL |
| CARBO ANIMALIS | 15 [hp_X]/mL |
| BOS TAURUS BILE | 4 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 9 [hp_X]/mL |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | 8 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 30 [hp_X]/mL |
| GENTIANA LUTEA ROOT | 1 [hp_X]/mL |
| INDOLE | 12 [hp_X]/mL |
| SKATOLE | 12 [hp_X]/mL |
| AVENA SATIVA FLOWERING TOP | 1 [hp_X]/mL |
| CHELIDONIUM MAJUS | 1 [hp_X]/mL |
| RADISH | 8 [hp_X]/mL |
| ALFALFA | 1 [hp_X]/mL |
| ANTIMONY TRISULFIDE | 15 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| FQ3DRG0N5K | Internal UNII lookup |
| GID333S43J | Internal UNII lookup |
| 4VBP01X99F | Internal UNII lookup |
| 2788Z9758H | Internal UNII lookup |
| XKC1657P78 | Internal UNII lookup |
| BQN1B9B9HA | Internal UNII lookup |
| 2P3VWU3H10 | Internal UNII lookup |
| 1TH8Q20J0U | Internal UNII lookup |
| J3TO6BUQ37 | Internal UNII lookup |
| 279O8I0433 | Internal UNII lookup |
| ET3651ZLOU | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| HF539G9L3Q | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
| S72O3284MS | Internal UNII lookup |
| 8724FJW4M5 | Internal UNII lookup |
| 9W945B5H7R | Internal UNII lookup |
| MA9CQJ3F7F | Internal UNII lookup |
| 7E889U5RNN | Internal UNII lookup |
| EM5RP35463 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bad8bfa1-a882-65b1-e053-2995a90a02f7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63479-0204-1 | B04DIGESTION | 30 mL in 1 BOTTLE, GLASS | SOLUTION/ DROPS | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63479-0204 | B04 DIGESTION (ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM) SOLUTION/ DROPS [APEX ENERGETICS INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_bad8bfa1-a882-65b1-e053-2995a90a02f7.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 |
|---|---|---|---|---|---|---|
| B04 DIGESTION | ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM | Apex Energetics Inc. | bad8bfa1-a882-65b1-e053-2995a90a02f7 | 2024-01-08 | Warnings | 63479-0204-1 63479-0204 63479020401 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63479-0204-1 | 63479020401 | 30 mL in 1 BOTTLE, GLASS (63479-0204-1) | 30 ml | 1994-12-15 | 0000-00-00 | No | No | Current |