Epsom Salt

Product NDC: 36800-395
11-digit product format: 368000395
Labeler code: 36800
Product ID: 36800-395_e587abe0-64ee-4bad-814c-9f96f4b36859
Type: HUMAN OTC DRUG
Nonproprietary name: Magnesium sulfate
Dosage form: GRANULE
Route: ORAL; TOPICAL
Labeler: TOP CARE (Topco Associates LLC)
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-04-30
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

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.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-395-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-395-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-395-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-395-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-395-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-395-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-395-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-395-04	`302b2466d912…`	`e7b80fea0513…`

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 table
Ingredient	Strength
MAGNESIUM SULFATE, UNSPECIFIED	1 g/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-395-01	Epsom Salt	454 g in 1 CARTON	GRANULE	454	12
36800-395-04	Epsom Salt	1810 g in 1 CARTON	GRANULE	1810	12
36800-395-10	Epsom Salt	454 g in 1 POUCH	GRANULE	454	12
36800-395-40	Epsom Salt	1814 g in 1 POUCH	GRANULE	1814	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-395	EPSOM SALT (MAGNESIUM SULFATE) GRANULE [TOP CARE (TOPCO ASSOCIATES LLC)]	11	Current NDC, Legacy NDC, 4 package rows	20250316_b1222ba6-390d-478d-905b-994fff4d6d58.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.

Matched openFDA labels page 32 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pure and Gentle Laxative	SODIUM PHOSPHATE	Medline Industries, LP	e3165538-75dd-4f0f-adc8-d4075de10f1e	2024-11-26	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 50 MG	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	af7533e6-8b06-48a4-940e-7ecb57b24b59	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a923e5ca-86fd-4bf9-9931-180ddfdeae66	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	7cf1df18-d658-4bff-8a62-365fc5656942	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	c5bdfbfc-d24a-4088-9b60-ecea8120ff43	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b10fdf50-289e-41f3-9b83-a4e4dd892f88	2024-11-21	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	85c64624-428d-46fa-8071-f42b8feec049	2024-11-21	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0	2024-11-21	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Walgreen Co.	d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5	2024-11-21	Warnings	Exact identifier application number: M007
4718 Enema, Mineral Oil	4718 ENEMA, MINERAL OIL	Dynarex	9e51c852-9477-5cf5-e053-2a95a90a97db	2024-11-20	Warnings	Exact identifier application number: M007
Relief	SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	Leosons Overseas Corp	5b301d5b-1e2c-47ed-a05f-d6be0fdfc940	2024-11-19	Warnings	Exact identifier application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Leosons Overseas Corp	90e7c2b4-35e1-4a27-afea-9257c480e190	2024-11-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM 100MG	PuraCap Pharmaceutical LLC	272c86f1-f229-2ebf-e063-6394a90a3471	2024-11-18	Warnings	Exact identifier application number: M007
Milk of Magnesia Concentrate	MAGNESIUM HYDROXIDE	PAI Holdings, LLC dba PAI Pharma	2a99a1a8-a830-429f-9cfd-3f29c3d3547c	2024-11-12	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	122486e9-74dd-4181-97d1-0b07688280f4	2024-11-06	Warnings	Exact identifier application number: M007
Stratuscare Adult Glycerin	GLYCERIN	Stratus Pharmaceuticals	3e1935da-5c1f-4942-98dd-320fade82321	2024-11-04	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	fdf3c8e1-d554-4cdb-e053-6394a90a542e	2024-11-01	Warnings	Exact identifier application number: M007
Stratuscare Glycerin Laxative Pediatric	GLYCERIN	Stratus Pharmaceuticals	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	2024-11-01	Warnings	Exact identifier application number: M007
Rite Aid Fiber Therapy	METHYLCELLULOSE	RITE AID CORPORATION	e50cea80-c020-4b85-b61f-d053f11f479b	2024-10-30	Warnings	Exact identifier application number: M007
Rite Aid Fiber Caplets	CALCIUM POLYCARBOPHIL	RITE AID CORPORATION	06e46cb0-2928-479e-984d-2305fff995e0	2024-10-30	Warnings	Exact identifier application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053346	Epsom salt 100 % Granules for Oral Solution	PSN	b1222ba6-390d-478d-905b-994fff4d6d58	12
1053346	magnesium sulfate 1000 MG Granules for Oral Solution	SCD	b1222ba6-390d-478d-905b-994fff4d6d58	12
1053346	Epsom salt 100 % Granules for Oral Solution	SY	b1222ba6-390d-478d-905b-994fff4d6d58	12
1053346	magnesium sulfate 100 % Granules for Oral Solution	SY	b1222ba6-390d-478d-905b-994fff4d6d58	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-395-01	36800039501	454 g in 1 CARTON (36800-395-01)	454 g	2014-04-30	0000-00-00	No	No	Current
36800-395-04	36800039504	1810 g in 1 CARTON (36800-395-04)	1810 g	2014-04-30	0000-00-00	No	No	Current
36800-395-10	36800039510	454 g in 1 POUCH (36800-395-10)	454 g	2014-04-30	0000-00-00	No	No	Current
36800-395-40	36800039540	1814 g in 1 POUCH (36800-395-40)	1814 g	2014-04-30	0000-00-00	No	No	Current