Spleenex
- Product NDC
- 44911-0294
- Requested package NDC
- 44911-0294-1
- 11-digit product format
- 449110294
- Labeler code
- 44911
- Product ID
- 44911-0294_99ef1e8f-d0f2-463d-afea-931b65a3abea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aralia Quinquefolia, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Niccolum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Baryta Carbonica, Phosphoricum Acidum, Aconiticum Acidum, Cis, Magnesium Gluconicum Dihydricum, Nux Vomica, Phosphorus
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Energique, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2015-11-11
- Substance
- AMERICAN GINSENG; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COBALT; NICKEL; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; NAPHTHOQUINE; BARIUM CARBONATE; PHOSPHORIC ACID; ACONITIC ACID, (Z)-; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS
- Active strength
- 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], 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 Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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… |
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
- Spleenex
- Brand name suffix
- VH
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMERICAN GINSENG | 3 [hp_X]/mL |
| GINKGO | 6 [hp_X]/mL |
| SUS SCROFA PANCREAS | 6 [hp_X]/mL |
| SUS SCROFA SPLEEN | 6 [hp_X]/mL |
| SUS SCROFA STOMACH | 6 [hp_X]/mL |
| GERMANIUM SESQUIOXIDE | 8 [hp_X]/mL |
| COBALT | 8 [hp_X]/mL |
| NICKEL | 8 [hp_X]/mL |
| ZINC | 8 [hp_X]/mL |
| OXOGLURIC ACID | 8 [hp_X]/mL |
| ANHYDROUS CITRIC ACID | 8 [hp_X]/mL |
| FUMARIC ACID | 8 [hp_X]/mL |
| MALIC ACID | 8 [hp_X]/mL |
| PYRUVIC ACID | 8 [hp_X]/mL |
| SUCCINIC ACID | 8 [hp_X]/mL |
| NAPHTHOQUINE | 9 [hp_X]/mL |
| BARIUM CARBONATE | 12 [hp_X]/mL |
| PHOSPHORIC ACID | 12 [hp_X]/mL |
| ACONITIC ACID, (Z)- | 12 [hp_X]/mL |
| MAGNESIUM GLUCONATE | 12 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 12 [hp_X]/mL |
| PHOSPHORUS | 12 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8W75VCV53Q | Internal UNII lookup |
| 19FUJ2C58T | Internal UNII lookup |
| 9Y3J3362RY | Internal UNII lookup |
| 92AMN5J79Y | Internal UNII lookup |
| T0920P9Z9A | Internal UNII lookup |
| 96WE91N25T | Internal UNII lookup |
| 3G0H8C9362 | Internal UNII lookup |
| 7OV03QG267 | Internal UNII lookup |
| J41CSQ7QDS | Internal UNII lookup |
| 8ID597Z82X | Internal UNII lookup |
| XF417D3PSL | Internal UNII lookup |
| 88XHZ13131 | Internal UNII lookup |
| 817L1N4CKP | Internal UNII lookup |
| 8558G7RUTR | Internal UNII lookup |
| AB6MNQ6J6L | Internal UNII lookup |
| TRY8UD4E2H | Internal UNII lookup |
| 6P669D8HQ8 | Internal UNII lookup |
| E4GA8884NN | Internal UNII lookup |
| OF5471ZHRR | Internal UNII lookup |
| T42NAD2KHC | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54e2c88e-2483-4c38-86e5-19e218e713ae | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44911-0294-1 | 2024-10-30 | C162847 | 48780-1 | d6a99b39-ee44-a426-e053-dadaa90af4c2 | DRUG FACTS: |
| 44911-0294-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ee44-a426-e053-dadaa90af4c2 | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44911-0294-1 | SpleenexVH | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44911-0294 | SPLEENEX VH (ARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241101_54e2c88e-2483-4c38-86e5-19e218e713ae.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 |
|---|---|---|---|---|---|---|
| Spleenex VH | ARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUS | Energique, Inc. | 54e2c88e-2483-4c38-86e5-19e218e713ae | 2024-10-30 | Warnings | 44911-0294-1 44911-0294 44911029401 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 44911-0294-1 | 44911029401 | 30 mL in 1 BOTTLE, DROPPER (44911-0294-1) | 30 ml | 2015-11-11 | 0000-00-00 | No | No | Current |