FDA.reportPublic FDA data

Epsom Salt

Product NDC
46122-461
11-digit product format
461220461
Labeler code
46122
Product ID
46122-461_17da0d80-49a3-4045-881b-a925fa8ab180
Type
HUMAN OTC DRUG
Nonproprietary name
Epsom Salt
Dosage form
GRANULE
Route
ORAL; TOPICAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-30
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
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

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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-46146122-461-19DDiscontinued by firm2026-10-15

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
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SK47B8698TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d22fb02f-09c4-476a-b6d6-d3a2fd30049dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-461-19Epsom Salt1814 g in 1 POUCHGRANULE181411
46122-461-43Epsom Salt454 g in 1 POUCHGRANULE45411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-461-19GM - Gram46122-4619be6c5d0-71ce-44f9-af0b-56c7a1b76e8f12019-03-12
46122-461-43GM - Gram46122-46128871e56-e4a8-4b68-9127-3240299a259212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-461EPSOM SALT GRANULE [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]11Current NDC, Legacy NDC, 2 package rows20250227_d22fb02f-09c4-476a-b6d6-d3a2fd30049d.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 21 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fiber Therapy Sugar FreePSYLLIUM HUSKPUBLIX SUPER MARKETS, INCed3dc80a-a243-4013-9886-b148e3e3b6622025-10-28WarningsExact identifier
application number: M007
Childrens Oral Saline LaxativeMAGNESIUM HYDROXIDEWAL-MART STORES,INC.,a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc2025-10-27WarningsExact identifier
application number: M007
equate Fiber TherapyMETHYLCELLULOSEWal-Mart Stores,Inc.,7acc30b4-e946-42cd-8eec-cf15159d478d2025-10-27WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCVS Pharmacyc56e010a-7503-3e1c-e053-2a95a90a2b852025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLMajor Pharmaceuticalsc194c40c-c732-2f03-e053-2a95a90a7a402025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLPharmacy Value Alliance LLC8a6d6729-f6eb-4f68-e053-2a95a90a5c9e2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCardinal Healthc2b33e78-6ab7-1785-e053-2995a90a9c4f2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSNd22fb02f-09c4-476a-b6d6-d3a2fd30049d11
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCDd22fb02f-09c4-476a-b6d6-d3a2fd30049d11
1053346Epsom salt 100 % Granules for Oral SolutionSYd22fb02f-09c4-476a-b6d6-d3a2fd30049d11
1053346magnesium sulfate 100 % Granules for Oral SolutionSYd22fb02f-09c4-476a-b6d6-d3a2fd30049d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-461-19461220461191814 g in 1 POUCH (46122-461-19) 1814 g2017-12-310000-00-00NoNoCurrent
46122-461-4346122046143454 g in 1 POUCH (46122-461-43) 454 g2018-05-300000-00-00NoNoCurrent