FDA.reportPublic FDA data

MINTOX MAXIMUM STRENGTH

Product NDC
0904-5725
11-digit product format
009045725
Labeler code
0904
Product ID
0904-5725_092ff042-828f-4851-e063-6394a90aade4
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
MAJOR Pharmaceuticals Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-01
Substance
ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength
400; 40; 400 mg/5mL; mg/5mL; mg/5mL
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], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MINTOX MAXIMUM STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/5mL
DIMETHICONE40 mg/5mL
MAGNESIUM HYDROXIDE400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S
Rxcui237870, 708127

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
0904-5725-14MINTOX MAXIMUM STRENGTH355 mL in 1 BOTTLESUSPENSION3553

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5725-14ML - Milliliter0904-5725bdefd943-80db-4a30-a73c-f839d6f87baf12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HYDROXIDE IONACTIVE MOIETY9159UV381PMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
HYDROXIDE IONACTIVE MOIETY9159UV381PMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5725MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20231103_536b143d-a1d7-4972-a90b-248e41937070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSNac6a47e7-972f-4b82-96da-89926d345e9f9
708127Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral SuspensionPSNac6a47e7-972f-4b82-96da-89926d345e9f9
708127aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]SBDac6a47e7-972f-4b82-96da-89926d345e9f9
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCDac6a47e7-972f-4b82-96da-89926d345e9f9
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSYac6a47e7-972f-4b82-96da-89926d345e9f9
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSYac6a47e7-972f-4b82-96da-89926d345e9f9
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSYac6a47e7-972f-4b82-96da-89926d345e9f9
708127Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral SuspensionSYac6a47e7-972f-4b82-96da-89926d345e9f9
708127Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral SuspensionSYac6a47e7-972f-4b82-96da-89926d345e9f9
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN5b1f4c78-d42e-32c7-e053-2991aa0a19855
708127Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral SuspensionPSN5b1f4c78-d42e-32c7-e053-2991aa0a19855
708127aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]SBD5b1f4c78-d42e-32c7-e053-2991aa0a19855
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD5b1f4c78-d42e-32c7-e053-2991aa0a19855
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY5b1f4c78-d42e-32c7-e053-2991aa0a19855
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY5b1f4c78-d42e-32c7-e053-2991aa0a19855
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY5b1f4c78-d42e-32c7-e053-2991aa0a19855
708127Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral SuspensionSY5b1f4c78-d42e-32c7-e053-2991aa0a19855
708127Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral SuspensionSY5b1f4c78-d42e-32c7-e053-2991aa0a19855
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSNb7711b50-c14a-44d6-b647-1f31284f87ea4
708127Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral SuspensionPSNb7711b50-c14a-44d6-b647-1f31284f87ea4
708127aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]SBDb7711b50-c14a-44d6-b647-1f31284f87ea4
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCDb7711b50-c14a-44d6-b647-1f31284f87ea4
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSYb7711b50-c14a-44d6-b647-1f31284f87ea4
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSYb7711b50-c14a-44d6-b647-1f31284f87ea4
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSYb7711b50-c14a-44d6-b647-1f31284f87ea4
708127Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral SuspensionSYb7711b50-c14a-44d6-b647-1f31284f87ea4
708127Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral SuspensionSYb7711b50-c14a-44d6-b647-1f31284f87ea4
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN536b143d-a1d7-4972-a90b-248e419370703
708127Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral SuspensionPSN536b143d-a1d7-4972-a90b-248e419370703
708127aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]SBD536b143d-a1d7-4972-a90b-248e419370703
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD536b143d-a1d7-4972-a90b-248e419370703
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY536b143d-a1d7-4972-a90b-248e419370703
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY536b143d-a1d7-4972-a90b-248e419370703
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY536b143d-a1d7-4972-a90b-248e419370703
708127Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral SuspensionSY536b143d-a1d7-4972-a90b-248e419370703
708127Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral SuspensionSY536b143d-a1d7-4972-a90b-248e419370703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5725-1400904572514355 mL in 1 BOTTLE (0904-5725-14) 355 ml2016-11-010000-00-00NoNoCurrent