Epsom Salt
- Product NDC
- 68196-395
- 11-digit product format
- 681960395
- Labeler code
- 68196
- Product ID
- 68196-395_ed82e4a3-2cf6-44be-997a-f3be68b3b780
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Magnesium sulfate
- Dosage form
- GRANULE
- Route
- ORAL; TOPICAL
- Labeler
- Sam's West, Inc
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-02-28
- Substance
- MAGNESIUM SULFATE, UNSPECIFIED
- Active strength
- 1 g/g
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- 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
- Epsom Salt
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MAGNESIUM SULFATE, UNSPECIFIED | 1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| DE08037SAB | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1053346 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68196-395-07 | Epsom Salt | 3175 g in 1 POUCH | GRANULE | 3175 | 11 | |
| 68196-395-14 | Epsom Salt | 3175 g in 1 POUCH | GRANULE | 3175 | 11 | |
| 68196-395-14 | Epsom Salt | 2 in 1 PACKAGE, COMBINATION | GRANULE | 2 | 11 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053346 | Epsom salt 100 % Granules for Oral Solution | PSN | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 11 |
| 1053346 | magnesium sulfate 1000 MG Granules for Oral Solution | SCD | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 11 |
| 1053346 | Epsom salt 100 % Granules for Oral Solution | SY | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 11 |
| 1053346 | magnesium sulfate 100 % Granules for Oral Solution | SY | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68196-395-07 | 68196039507 | 3175 g in 1 POUCH (68196-395-07) | 3175 g | 2019-02-28 | 0000-00-00 | No | No | Current |
| 68196-395-14 | 68196039514 | 2 POUCH in 1 PACKAGE, COMBINATION (68196-395-14) / 3175 g in 1 POUCH | 2 pouch | 2019-02-28 | 0000-00-00 | No | No | Current |