aluminum hydroxide, magnesium hydroxide, simethicone

Product NDC
24451-725
11-digit product format
244510725
Labeler code
24451
Product ID
24451-725_182d5565-8aa9-493e-a24e-712433bc9302
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
LLC Federal Solutions
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
400 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24451-725DDiscontinued by firm2026-10-05
excluded packagepackage24451-72524451-725-30DDiscontinued by firm2026-10-05

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage24451-725-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24451-725-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24451-725-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24451-725-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24451-725-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24451-725-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24451-725-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24451-725-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24451-725-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24451-725-30DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24451-725-30DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24451-725-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24451-725-30IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24451-725-302020-01-07C16284748780-19855d018-dad2-cd31-e053-dbdaa90ab51afc3c5c56-772f-44f8-b42f-88909ad68a5e
24451-725-302019-11-27C16284748780-19855d018-dad2-cd31-e053-dbdaa90ab51afc3c5c56-772f-44f8-b42f-88909ad68a5e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
SORBITOLINACTIVE INGREDIENT506T60A25RALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [LLC FEDERAL SOLUTIONS]1