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 |
|---|---|---|---|---|---|---|
| Fleet | BISACODYL | C.B. Fleet Company, Inc. | 324e61eb-8f6b-48d7-85c2-b1b5642691c9 | 2025-06-23 | Warnings | M007 |
| Saline Laxative | SODIUM PHOSPHATE | Walgreen Company | fb260df0-7bda-4299-84a5-44c8f9447798 | 2025-06-18 | Warnings | M007 |
| De La Cruz Castor Oil | CASTOR OIL | DLC Laboratories, Inc. | 22fbad2e-e9fa-46ba-8617-ad79483cbe9a | 2025-06-13 | Warnings | M007 |
| Prolaxa | DOCUSATE SODIUM 250MG | Terrain Pharmaceuticals | 32610e42-f352-09fd-e063-6394a90abff6 | 2025-06-12 | Warnings | M007 |
| DOCUZEN | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Village Pharma | 29102014-9b0e-4899-958d-83111f94a612 | 2025-06-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 364b558b-69b5-bfa4-e063-6294a90acd0c | 2025-05-29 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 364bc4f5-6337-6c89-e063-6394a90a12ab | 2025-05-29 | Warnings | M007 |
| SENNA | SENNOSIDES | AARNA USA INC. | 364d4dfc-a089-1a27-e063-6394a90ad77b | 2025-05-29 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 3634b4e4-4fea-9428-e063-6394a90a6ad9 | 2025-05-28 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | ATLANTIC BIOLOGICALS CORP. | 30fb7b5e-56a3-423e-ae57-432006b54fff | 2025-05-23 | Warnings | M007 |
| Senna Liquid | SENNA LIQUID | Belleview Biosciences | 35d5f217-b101-3cd8-e063-6394a90adccd | 2025-05-23 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 816c82f8-0fa5-4b22-a226-e8f22f3eaa1d | 2025-05-23 | Warnings | M007 |
| Senna Laxative | SENNA | PD-Rx Pharmaceuticals, Inc. | 2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa | 2025-05-21 | Warnings | M007 |
| Senna | SENNOSIDES | Akron Pharma Inc. | 55ce3969-d7a6-49c4-8c13-d95690efc1a6 | 2025-05-16 | Warnings | M007 |
| Saline Enema | SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC | Dynarex Corporation | 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 | 2025-05-14 | Warnings | M007 |
| Bisacodyl | BISACODYL | Rising Pharma Holdings, Inc. | 03429da4-1ce9-4789-bf54-ce1b3215b013 | 2025-05-13 | Warnings | M007 |
| COLACE EXTRA STRENGTH STOOL SOFTNER | DOCUSATE SODIUM | Atlantis Consumer Healthcare Inc. | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 2025-05-01 | Warnings | M007 |
| Senna | SENNOSIDES | PAI Holdings, LLC dba PAI Pharma | 7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed | 2025-04-28 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Belleview Bio Science | 335f41d7-5c22-7c17-e063-6294a90a8f28 | 2025-04-22 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | American Health Packaging | e5028f6d-d33d-47a9-8453-00af5cdf59a6 | 2025-04-20 | 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 |