Home NDC 65197-300 Gelusil
Product NDC 65197-300
11-digit product format 651970300
Labeler code 65197
Product ID 65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101
Type HUMAN OTC DRUG
Nonproprietary name Alumina, Magnesia, Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WellSpring Pharmaceutical Corporation
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-09-24
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE
Active strength 200; 200; 24; 1 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 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 65197-300-20 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gelusil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 200 mg/1 MAGNESIUM HYDROXIDE 200 mg/1 DIMETHICONE, UNSPECIFIED 24 mg/1 SILICON DIOXIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211633 Internal RxNorm lookup 307747 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-300-10 Gelusil 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 26 65197-300-10 Gelusil 10 in 1 CARTON TABLET, CHEWABLE 10 26 65197-300-11 Gelusil 100 in 1 BOTTLE TABLET, CHEWABLE 100 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 SILICON DIOXIDE ACTIVE INGREDIENT ETJ7Z6XBU4 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 MAGNESIUM CATION ACTIVE MOIETY T6V3LHY838 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 SILICON DIOXIDE ACTIVE MOIETY ETJ7Z6XBU4 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 MANNITOL INACTIVE INGREDIENT 3OWL53L36A GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 RAW SUGAR INACTIVE INGREDIENT 8M707QY5GH GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10 SORBITOL INACTIVE INGREDIENT 506T60A25R GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-300 GELUSIL (ALUMINA, MAGNESIA, SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] 25 Current NDC, Legacy NDC, 3 package rows 20250110_92fbeec1-1562-40f3-9734-41f133d494f9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 36 · 719 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Stomach Relief CALCIUM CARBONATE Wal-Mart Stores Inc 7471ec99-6c0b-40d8-a9cf-85240a0d471a 2026-09-09 Warnings Exact identifier application number: M001 Walgreens Orange Antacid Soft Chew CALCIUM CARBONATE Walgreens 5b01be31-5871-d4f5-e063-6294a90a671a 2026-09-08 Warnings Exact identifier application number: M001 Regular Strength Tropical Fruit CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 38c6cece-71a0-40d8-bfc8-2f6467f9239b 2026-09-05 Warnings Exact identifier application number: M001 Extra Strength Antacid Assorted Berries CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 07a50168-6b05-4c99-9969-7d7f0aa54f30 2026-09-05 Warnings Exact identifier application number: M001 DRx CHOICE Antacid Calcium Regular Strength CALCIUM CARBONATE 500MG Raritan Pharmaceuticals Inc 0c579405-9397-4bf2-8441-e89011b19ec4 2026-09-05 Warnings Exact identifier application number: M001 Tums Chewy Bites Wintermint and Vanilla Cream CALCIUM CARBONATE Haleon US Holdings LLC 4f094feb-8de1-4ccb-e063-6294a90acec2 2026-09-04 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE DOLGENCORP, LLC 98a0503c-add5-4453-9d9d-6f813866f4b3 2026-09-03 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE DOLGENCORP, LLC 99c7ab95-df12-4041-ae1a-398cc6f0085d 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Ultra Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Liquid Antacid plus Anti Gas CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE DOLGENCORP, LLC 8ecb4418-e647-49b5-b418-1c63bb3e5a3c 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 4942747a-8b6c-422a-8150-9bd91c0a3778 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Regular Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC 13dd2758-a372-4b0e-bc99-56a2dacbf95f 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid Wintergreen flavor CALCIUM CARBONATE DOLGENCORP, LLC b84b3509-3178-4616-9bec-dad85a4f9d2a 2026-09-03 Warnings Exact identifier application number: M001 DG Health Regular Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 59ad3cc7-4144-442f-a37d-75c5fe23e1ae 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Assorted Fruits Antacid CALCIUM CARBONATE DOLGENCORP, LLC 112f1002-c007-4363-ade6-8dfbc61f4b64 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid SMOOTH DISSOLVE CALCIUM CARBONATE DOLGENCORP, LLC cabaa8f7-9c93-439d-905a-5ef643a08ea8 2026-09-03 Warnings Exact identifier application number: M001 Kroger Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE THE KROGER CO., 175d9f0f-266a-4dc2-865f-d1ebd4ddac51 2026-09-01 Warnings Exact identifier application number: M001 Kids Antacid CALCIUM CARBONATE THE KROGER CO. d77c629b-5308-4b71-9024-9899cf88dbae 2026-09-01 Warnings Exact identifier application number: M001 Kroger Extra Strength Smooth Antacid Assorted Berry CALCIUM CARBONATE KROGER COMPANY 4c8d39d9-9d58-45df-9ffd-2cdc41539c03 2026-09-01 Warnings Exact identifier application number: M001 Kroger Ultra Strength Assorted Fruit CALCIUM CARBONATE KROGER COMPANY b60ced06-725c-4dae-abbf-21cab9e431f9 2026-08-31 Warnings Exact identifier application number: M001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65197-300-10 65197030010 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 10 blister pack 2008-09-24 0000-00-00 No No Current 65197-300-11 65197030011 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11) 2018-12-01 0000-00-00 No No Current