Mintox Plus Tabs

Product NDC
0904-0478
11-digit product format
009040478
Labeler code
0904
Product ID
0904-0478_37d4b88e-89ba-48fa-aba3-302fe6b3c91f
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-03-14
Marketing end
0000-00-00
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
200 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0904-0478DDiscontinued by firm2026-10-16
excluded packagepackage0904-04780904-0478-60DDiscontinued by firm2026-10-16

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-0478-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-0478-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-0478-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-0478-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-0478-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-0478-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-0478-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-0478-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-0478-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-0478-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-0478-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-0478-60557ba5c1ecfa…9c80585c8c6e…

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
0904-0478-60EA - Each0904-0478f64d0fe3-0837-4382-b573-11ff1c77347d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0MINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0MINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
HYDROXIDE IONACTIVE MOIETY9159UV381PMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554MINTOX PLUS TABS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]1