FDA.reportPublic FDA data

Magnesium Citrate

Product NDC
63868-935
Requested package NDC
63868-935-10
11-digit product format
638680935
Labeler code
63868
Product ID
63868-935_f69f9485-2dc8-4fe9-b776-1f6e70677c19
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium citrate
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-30
Marketing end
2025-02-28
Substance
MAGNESIUM CITRATE
Active strength
2 g/29.6mL
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 packagepackage63868-93563868-935-10DDiscontinued by firm2026-10-12

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-935-10ML - Milliliter63868-935ed2f891f-d77a-4b48-9998-5b1f7298207412014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM CITRATEACTIVE INGREDIENTRHO26O1T9VMAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
WATERINACTIVE INGREDIENT059QF0KO0RMAGNESIUM CITRATE LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-935-1063868093510296 mL in 1 BOTTLE, GLASS (63868-935-10) 296 ml2014-06-302025-02-28NoNoCurrent