Glutenstat
- Product NDC
- 44911-0670
- 11-digit product format
- 449110670
- Labeler code
- 44911
- Product ID
- 44911-0670_4884ad84-694d-41dc-9946-63e1cf2696b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alfalfa, Zingiber Officinale, Cinchona Officinalis, Hydrastis Canadensis, Barley (Grain), Carbo Vegetabilis, Glyphosate, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Oat (Grain), Pulsatilla (Vulgaris), Rye (Grain), Wheat (Grain), Gluten
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Energique, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2023-04-05
- Substance
- ACTIVATED CHARCOAL; BARLEY; CINCHONA OFFICINALIS BARK; GINGER; GLYPHOSATE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MEDICAGO SATIVA WHOLE; OAT; PULSATILLA VULGARIS WHOLE; RYE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; WHEAT; WHEAT GLUTEN
- Active strength
- 12; 12; 6; 4; 12; 6; 12; 4; 12; 12; 12; 12; 12; 12; 16 [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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glutenstat
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MEDICAGO SATIVA WHOLE | 12 [hp_X]/mL |
| GINGER | 12 [hp_X]/mL |
| CINCHONA OFFICINALIS BARK | 6 [hp_X]/mL |
| GOLDENSEAL | 4 [hp_X]/mL |
| BARLEY | 12 [hp_X]/mL |
| ACTIVATED CHARCOAL | 6 [hp_X]/mL |
| GLYPHOSATE | 12 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 4 [hp_X]/mL |
| SODIUM CHLORIDE | 12 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 12 [hp_X]/mL |
| OAT | 12 [hp_X]/mL |
| PULSATILLA VULGARIS WHOLE | 12 [hp_X]/mL |
| RYE | 12 [hp_X]/mL |
| WHEAT | 12 [hp_X]/mL |
| WHEAT GLUTEN | 16 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| DJO934BRBD | Internal UNII lookup |
| C5529G5JPQ | Internal UNII lookup |
| S003A158SB | Internal UNII lookup |
| ZW3Z11D0JV | Internal UNII lookup |
| 5PWM7YLI7R | Internal UNII lookup |
| 2P3VWU3H10 | Internal UNII lookup |
| 4632WW1X5A | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
| Z6J799EAJK | Internal UNII lookup |
| I76KB35JEV | Internal UNII lookup |
| 0R4AQI398X | Internal UNII lookup |
| 4J2I0SN84Y | Internal UNII lookup |
| 1534K8653J | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6b867b6-74d9-4725-90d7-7d5d1fe61121 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44911-0670-1 | Glutenstat | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44911-0670 | GLUTENSTAT (ALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN) LIQUID [ENERGIQUE, INC.] | 1 | Current NDC, 1 package rows | 20230406_c6b867b6-74d9-4725-90d7-7d5d1fe61121.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 |
|---|---|---|---|---|---|---|
| Glutenstat | ALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN | Energique, Inc. | c6b867b6-74d9-4725-90d7-7d5d1fe61121 | 2023-04-05 | Warnings | 44911-0670 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 44911-0670-1 | 44911067001 | 30 mL in 1 BOTTLE, DROPPER (44911-0670-1) | 30 ml | 2023-04-05 | No | No | Current |