Home NDC 37205-535 Leader Antacid
Product NDC 37205-535
11-digit product format 372050535
Labeler code 37205
Product ID 37205-535_774b6603-c55b-4844-bebc-5548cb93c131
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Cardinal Health
Application part331
Marketing category OTC MONOGRAPH FINAL
Marketing start 1990-05-15
Marketing end 0000-00-00
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 800 mg/10mL; mg/10mL; mg/10mL
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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 37205-535-40 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 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 MAGNESIUM CATION ACTIVE MOIETY T6V3LHY838 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CARDINAL HEALTH] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 37205-535-40 37205053540 355 mL in 1 BOTTLE (37205-535-40) 355 ml 1990-05-15 0000-00-00 No No Current