Epsom Salt
- Product NDC
- 68016-732
- 11-digit product format
- 680160732
- Labeler code
- 68016
- Product ID
- 68016-732_5d9a7894-cc5b-42bd-aed4-f5eb226abf42
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Magnesium sulfate
- Dosage form
- GRANULE
- Route
- ORAL; TOPICAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-08-31
- Marketing end
- 2026-12-31
- 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
- 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68016-732-04 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68016-732-06 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68016-732-01 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68016-732-04 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68016-732-06 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68016-732-01 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68016-732-04 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68016-732-06 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68016-732-01 | 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
- Epsom Salt
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 |
|---|---|
| c9807e6e-9dcc-41a2-8956-b61623ac2176 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68016-732-01 | 2022-10-14 | Drug Facts |
| 68016-732-04 | 2022-10-14 | Drug Facts |
| 68016-732-06 | 2022-10-14 | Drug Facts |
| 68016-732-01 | 2022-01-28 | Drug Facts |
| 68016-732-04 | 2022-01-28 | Drug Facts |
| 68016-732-06 | 2022-01-28 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-732-01 | Epsom Salt | 454 g in 1 POUCH | GRANULE | 454 | 10 | |
| 68016-732-04 | Epsom Salt | 1814 g in 1 POUCH | GRANULE | 1814 | 10 | |
| 68016-732-06 | Epsom Salt | 2720 g in 1 POUCH | GRANULE | 2720 | 10 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stool Softener Extra Strength | DOCUSATE SODIUM | MEIJER, INC. | e43bd2ed-17c7-4530-af72-81a7ad70069c | 2023-10-12 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Care One (Retail Business Services, LLC.) | 9adaec97-43e3-48f2-96c8-c508b693676c | 2023-10-05 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | TopCo Associates, LLC | 83aeb90a-ab00-4e26-aa44-5259dce59018 | 2021-04-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 9fbe783e-ddd9-445a-852a-00f4ad754880 | 2021-04-20 | Warnings | M007 |
| Topcare Stool Softener | DOCUSATE SODIUM | TopCo Associates, LLC | 6f4fddda-4129-4087-b0e4-ababc5558484 | 2021-02-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 30c9ff75-cee4-4632-86fd-acfdf5ee85af | 2020-10-27 | Warnings | M007 |
| Stool Softener | MARC GLASSMAN | Marc Glassman, Inc. | 909cd222-d836-416f-aa7d-deb4a0c5a560 | 2020-09-08 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | Allegiant Health | 94a9c24a-07c3-4535-b810-b7abc9fc5ad5 | 2019-12-11 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Marc Glassman, Inc. | ec34fc1e-d122-4fa4-859e-e89e3e12edd5 | 2019-09-18 | Warnings | M007 |
| Womens Laxative | BISACODYL | Marc Glassman, Inc. | aeb3c49b-cbf5-4a47-b19c-e77fbb987a49 | 2019-09-17 | Warnings | M007 |
| Bisacodyl 5mg | BISACODYL 5MG | Allegiant Health | 46a377f5-822b-496f-a73b-66d8f902680a | 2019-03-26 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Allegiant Health | 51f1c6c0-770c-4426-820b-bc1f42e143fd | 2019-02-07 | Warnings | M007 |
| Senna-Lax | SENNOSIDES | Marc Glassman, Inc. | 7dd97c54-2ba1-4629-87b9-1ba0913fe531 | 2016-12-27 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053346 | Epsom salt 100 % Granules for Oral Solution | PSN | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 10 |
| 1053346 | magnesium sulfate 1000 MG Granules for Oral Solution | SCD | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 10 |
| 1053346 | Epsom salt 100 % Granules for Oral Solution | SY | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 10 |
| 1053346 | magnesium sulfate 100 % Granules for Oral Solution | SY | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-732-01 | 68016073201 | 454 g in 1 POUCH (68016-732-01) | 454 g | 2017-08-31 | 2026-12-31 | No | No | Current |
| 68016-732-04 | 68016073204 | 1814 g in 1 POUCH (68016-732-04) | 1814 g | 2017-08-31 | 2026-12-31 | No | No | Current |
| 68016-732-06 | 68016073206 | 2720 g in 1 POUCH (68016-732-06) | 2720 g | 2017-08-31 | 2026-12-31 | No | No | Current |