Glutenstat
- Product NDC
- 44911-0430
- Requested package NDC
- 44911-0430-1
- 11-digit product format
- 449110430
- Labeler code
- 44911
- Product ID
- 44911-0430_03ff3be9-8007-45a3-9030-689227feb1d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alfalfa, Cinchona Officinalis, Zingiber Officinale, 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
- 2017-06-21
- Marketing end
- 0000-00-00
- Substance
- ALFALFA; CINCHONA OFFICINALIS BARK; GINGER; GOLDENSEAL; BARLEY; ACTIVATED CHARCOAL; GLYPHOSATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; OATMEAL; ANEMONE PULSATILLA; RYE; WHEAT; WHEAT GLUTEN
- Active strength
- 4 [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
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 44911-0430 | 44911-0430-1 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44911-0430-1 | 2023-02-03 | C162847 | 48780-1 | f386c64a-1536-0266-e053-dadaa90a7c1a | Drug Facts: |
| 44911-0430-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1536-0266-e053-dadaa90a7c1a | Drug Facts: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44911-0430-1 | Glutenstat | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44911-0430 | GLUTENSTAT (ALFALFA, CINCHONA OFFICINALIS, ZINGIBER OFFICINALE, 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.] | 3 | Legacy NDC, 1 package rows | 20230204_314c8276-dc9b-4654-8e0e-3b4c22db5b21.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, CINCHONA OFFICINALIS, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN | Energique, Inc. | 314c8276-dc9b-4654-8e0e-3b4c22db5b21 | 2023-02-03 | Warnings | 44911-0430-1 44911-0430 44911043001 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 44911-0430-1 | 44911043001 | 30 mL in 1 BOTTLE, DROPPER (44911-0430-1) | 30 ml | 2017-06-21 | 0000-00-00 | No | No | Current |