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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 65197-300 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 65197-300 | 65197-300-20 | D | Discontinued by firm | 2026-10-16 |
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.
| 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 |
|---|---|
| ALUMINUM HYDROXIDE | 200 mg/1 |
| MAGNESIUM HYDROXIDE | 200 mg/1 |
| DIMETHICONE, UNSPECIFIED | 24 mg/1 |
| SILICON DIOXIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5QB0T2IUN0 | Internal UNII lookup |
| NBZ3QY004S | Internal UNII lookup |
| 92RU3N3Y1O | Internal UNII lookup |
| ETJ7Z6XBU4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92fbeec1-1562-40f3-9734-41f133d494f9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65197-300-10 | EA - Each | 65197-300 | 8e370643-937c-4fe1-95c4-c2ce1d50c130 | 1 | 2012-07-24 |
| 65197-300-11 | EA - Each | 65197-300 | bdc6445f-2da5-4c62-8ddd-a4e3be901ec9 | 1 | 2020-06-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tums Chewy Bites | CALCIUM CARBONATE | Navajo Manufacturing Company Inc. | 297d6703-ed4e-10d3-e063-6394a90a9f3a | 2024-12-17 | Warnings | M001 |
| Calcium Carbonate 10 gr (648 mg) (Antacid) | CALCIUM CARBONATE 10GR (648 MG) | RUGBY LABORATORIES | f21c8cf7-45cb-492b-bf4a-462024a54569 | 2024-12-17 | Warnings | M001 |
| Extra Strength Antacid Tablets, Caseys 4good | CALCIUM CARBONATE 750 MG | Lil' Drug Store Prodsucts, Inc. | 026aefd6-bb80-1ffd-e063-6394a90a1262 | 2024-12-16 | Warnings | M001 |
| Foster and Thrive Regular Strength Antacid | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 1aeb60fb-eebe-4e54-be1c-4e01f3b7269c | 2024-12-13 | Warnings | M001 |
| Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted Fruit | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 8b2fabf7-4dc6-445a-842c-b28ae081fdc8 | 2024-12-13 | Warnings | M001 |
| Foster and Thrive Regular Strength Antacid Peppermint | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 49d1b6c4-432b-44d3-b073-0185dbed7a90 | 2024-12-12 | Warnings | M001 |
| Mylanta Maximum Strength Classic Flavor | ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 56853b20-a2aa-4b19-a428-3dde232114c6 | 2024-12-11 | Warnings | M001 |
| Mylanta New Tonight Soothing Honey Chamomile | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 123f3005-a0a0-4970-94f1-f6d04741078b | 2024-12-11 | Warnings | M001 |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | NuCare Pharmaceuticals, Inc. | fd160cfd-9ad4-81c7-e053-6394a90a33f6 | 2024-12-11 | Warnings | M001 |
| Topcare Ultra Strength Antacid Peppermint | CALCIUM CARBONATE | Topco Associates, LLC | fb434059-7b6e-42e0-acfa-db9879f6a4e4 | 2024-12-11 | Warnings | M001 |
| TopCare Ultra Strength Antacid Assorted Fruit | CALCIUM CARBONATE | Topco Associates, LLC | dd038b15-2ecb-4ee2-b356-db6d87c2f01b | 2024-12-11 | Warnings | M001 |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | 74823298-d24a-4ffe-8446-1661305372b2 | 2024-12-11 | Warnings | M001 |
| Extra Strength Antacid Smooth Dissolve Assorted Fruit | CALCIUM CARBONATE | UNITED NATURAL FOODS, INC. DBA UNFI | 1b6a48a7-0703-2d3d-e063-6394a90a4641 | 2024-12-11 | Warnings | M001 |
| Careone Regular Strength Calcium Antacid | CALCIUM CARBONATE | Retail Business Services, LLC. | bdd9a64d-777b-45e0-8a9a-6cdc54baf898 | 2024-12-11 | Warnings | M001 |
| Careone Regular Strength calcium Antacid | CALCIUM CARBONATE | Retail Business Services, LLC. | cb6e12cc-4b88-4046-a9fc-2dbe4bca965e | 2024-12-11 | Warnings | M001 |
| TopCare Ultra Strength Antacid Assorted Berry | CALCIUM CARBONATE | Topco Associates, LLC | c10c56ba-51cf-47f9-80a8-aa188859608f | 2024-12-11 | Warnings | M001 |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | ce2edc57-e550-4aa9-bbfe-37933913c9eb | 2024-12-11 | Warnings | M001 |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | b8712a98-30b7-4154-a5bf-0095ef901412 | 2024-12-09 | Warnings | M001 |
| HEARTBURN RELIEF | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | GERI-CARE PHARMACEUTICALS, CORP | 1f1dbf41-cb87-37d4-e063-6394a90ae294 | 2024-12-09 | Warnings | M001 |
| MAXIMUM STRENGTH Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | 25c93d2a-3c48-ca3a-e063-6294a90a312e | 2024-12-09 | Warnings | M001 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307747 | aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet | PSN | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 211633 | Gelusil Antacid & Anti-Gas 200 MG / 200 MG / 25 MG Chewable Tablet | PSN | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 211633 | aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet [Gelusil] | SBD | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 307747 | aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet | SCD | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 307747 | aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG Chewable Tab | SY | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 211633 | Gelusil (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG) Chewable Tablet | SY | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
| 211633 | Gelusil Antacid & Anti-Gas (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG) Chewable Tablet | SY | 92fbeec1-1562-40f3-9734-41f133d494f9 | 26 |
Packages#
| 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 |