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 7 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mylanta All-Family Multi Symptom Stomach Remedy CALCIUM CARBONATE, SIMETHICONE Sportpharm LLC a70f113d-d5a3-44f5-b223-cd1b0e159e1a 2026-04-24 Warnings Exact identifier application number: M001 Genexa Kids Tummy Relief CALCIUM CARBONATE Genexa Inc. 4f9db9dc-6b78-d123-e063-6294a90ae38d 2026-04-16 Warnings Exact identifier application number: M001 Rugby Extra Strength Antacid CALCIUM CARBONATE Rugby Laboratories c15a5dde-6789-4491-98fd-d248a5c7f076 2026-04-15 Warnings Exact identifier application number: M001 Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Rugby Laboratories bd58baac-5790-455a-9c77-236680992579 2026-04-15 Warnings Exact identifier application number: M001 Rugby Extra Strength Antacid CALCIUM CARBONATE Rugby Laboratories 78f11b4b-d203-45c9-9b29-2c135eb66619 2026-04-15 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr. (650 mg) SODIUM BICARBONATE Gendose Pharmaceuticals, LLC 0a0cc46d-372e-4175-932a-065e82d8d353 2026-04-13 Warnings Exact identifier application number: M001 Extra Strength Antacid Calcium Carbonate, 750mg CALCIUM CARBONATE CHEWABLE TABLETS CVS HEALTH CORP 24cdab48-bcc7-e66f-e063-6394a90abbd7 2026-04-11 Warnings Exact identifier application number: M001 TUMS Smoothies CALCIUM CARBONATE Haleon US Holdings LLC c22944b8-8733-4689-be0c-f320467f79ea 2026-04-01 Warnings Exact identifier application number: M001 Soothe childrens CALCIUM CARBONATE Walgreen Company 0235e083-5f3d-4bae-b14a-b12db623180c 2026-03-31 Warnings Exact identifier application number: M001 Dulcolax Soft Chews Mixed Berry MAGNESIUM HYDROXIDE Chattem, Inc. fe71907c-b1eb-4433-9337-933a944f3e62 2026-03-31 Warnings Exact identifier application number: M001 AMAZON ULTRA STRENGTH ANTACID CALCIUM CARBONATE AMAZON.COM SERVICES LLC 36cf072c-ab61-47de-8fbc-f1d1d981ec84 2026-03-27 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Bryant Ranch Prepack f98cac25-63f2-478e-b785-20cba1c56565 2026-03-27 Warnings Exact identifier application number: M001 Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE Hyvee Inc 44eaa023-0f11-1256-e063-6394a90a4167 2026-03-26 Warnings Exact identifier application number: M001 Rapidol Sodium Bicarbonate SODIUM BICARBONATE Pharmadel LLC b4c9a653-6f51-7c98-e053-2995a90ada37 2026-03-26 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE Grocery Outlet, Inc. 4465441f-c518-8c1d-e063-6294a90a7407 2026-03-25 Warnings Exact identifier application number: M001 Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE Hyvee Inc 44ea74ce-2b9f-e578-e063-6394a90ab72d 2026-03-25 Warnings Exact identifier application number: M001 Antacid Melts CALCIUM CARBONATE 250MG Quest Products, LLC 4dcc5323-eafe-0dc8-e063-6294a90acb60 2026-03-24 Warnings Exact identifier application number: M001 Sodium Bicarbonate Antacid SODIUM BICARBONATE Aphena Pharma Solutions - Tennessee, LLC bba7d5bf-c94b-4ee4-a399-9a2818d84c78 2026-03-23 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Grocery Outlet, Inc. 44657e4a-6093-bcab-e063-6394a90a4837 2026-03-19 Warnings Exact identifier application number: M001 Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch CALCIUM CARBONATE AND SIMETHICONE Bayer HealthCare LLC. 41d17406-3653-4889-81df-6270b7b5d3c7 2026-03-12 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