CareOne Antacid

Product NDC
41520-588
Requested package NDC
41520-588-40
11-digit product format
415200588
Labeler code
41520
Product ID
41520-588_abcc392c-59fa-4484-86be-39344c56a69b
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Sales Company
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-10
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

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 packagepackage41520-58841520-588-40DDiscontinued 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-588-402023-11-16C16284748780-1f386c649-9ba3-0266-e053-dadaa90a7c1aAmerican Sales Company Liquid Antacid Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREONE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [AMERICAN SALES COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-588-4041520058840355 mL in 1 BOTTLE (41520-588-40) 355 ml2013-09-100000-00-00NoNoCurrent