Topcare Antacid

Product NDC
36800-340
Requested package NDC
36800-340-40
11-digit product format
368000340
Labeler code
36800
Product ID
36800-340_5179c1bf-86a0-4a80-aae6-05822b5c3979
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1990-07-15
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-34036800-340-40DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
36800-340-40ML - Milliliter36800-340973bfc98-80ec-4578-8c64-231122e68a5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004STOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE ANTACID PLUS ANTI GAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [TOPCO ASSOCIATES LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-340-4036800034040355 mL in 1 BOTTLE (36800-340-40) 355 ml1990-07-152022-02-28NoNoCurrent