Home NDC 36800-588 Topcare Antacid
Product NDC 36800-588
11-digit product format 368000588
Labeler code 36800
Product ID 36800-588_72578310-0fda-4db8-ba2d-5e0c53867da7
Type HUMAN OTC DRUG
Nonproprietary name Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Topco Associates LLC
Application part332
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-04-28
Marketing end 2022-02-28
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 800 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag No
Listing certified through 0000-00-00
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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 36800-588-40 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 TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 HYDROXIDE ION ACTIVE MOIETY 9159UV381P TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE ANTACID MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-588-40 36800058840 355 mL in 1 BOTTLE (36800-588-40) 355 ml 2006-04-28 0000-00-00 No No Current