Home NDC 0904-0005 MI-ACID MAXIMUM STRENGTH
Product NDC 0904-0005
11-digit product format 009040005
Labeler code 0904
Product ID 0904-0005_5de3f791-9357-94f7-e053-2991aa0a5b4e
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form SUSPENSION
Route ORAL
Labeler MAJOR Pharmaceuticals Inc.
Application part331
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-02-01
Marketing end 0000-00-00
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 400 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-0005-14 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-0005-14 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-0005-14 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-0005-14 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-0005-14 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-0005-14 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-0005-14 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-0005-14 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-0005-14 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-0005-14 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-0005-14 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-0005-14 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 HYDROXIDE ION ACTIVE MOIETY 9159UV381P MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MI-ACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [MAJOR PHARMACEUTICALS INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-0005-14 00904000514 355 mL in 1 BOTTLE (0904-0005-14) 355 ml 2017-06-01 0000-00-00 No No Current