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 |
|---|---|---|---|---|---|---|
| Leader Ultra Strength Antacid | CALCIUM CARBONATE | CARDINAL HEALTH 110, LLC. DBA LEADER | eab5a905-67fb-494e-8f55-aeeab4c2dce2 | 2025-08-22 | Warnings | M001 |
| Leader Extra Strength Antacid | CALCIUM CARBONATE | CARDINAL HEALTH 110, LLC. DBA LEADER | 81911f6d-7edf-4183-9720-2f20a5db498d | 2025-08-21 | Warnings | M001 |
| Gas Relief | SIMETHICONE | BJWC (Berkley & Jensen / BJ's) | 2f32dde8-502e-eefa-e063-6294a90abf20 | 2025-08-19 | Warnings | M001 |
| CVS Health Ultra Strength Natural Antacid Peppermint Flavor | ANTACID TABLETS | CVS Pharmacy,Inc. | 4f18fd8d-4d6a-4b1d-8a94-b64592f73ad0 | 2025-08-13 | Warnings | M001 |
| MGC Health Calcium Carbonate Antacid Assorted Berries | CALCIUM CARBONATE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | b84d80c6-0240-4276-8e47-74a918f3d86a | 2025-08-12 | Warnings | M001 |
| Antacid | CALCIUM CARBONATE | ProStat First Aid | 3bb49eb3-2eaa-af8d-e063-6294a90a4035 | 2025-08-06 | Warnings | M001 |
| Maximum Strength Antacid and Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Meijer, Inc. | 30a0455d-63e0-95cc-e063-6394a90ada6b | 2025-07-30 | Warnings | M001 |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Menper Distributors Inc. | 6efb4da0-03ae-4df6-acd7-e8023d20d4b3 | 2025-07-22 | Warnings | M001 |
| Gas-X Total Relief Maximum Strength | CALCIUM CARBONATE, SIMETHICONE | Haleon US Holdings LLC | edb0f11a-bdb7-484d-9257-09ff47b0fca4 | 2025-07-15 | Warnings | M001 |
| REGULAR STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | WALGREEN COMPANY | 7cd9234e-d1cc-4cce-e053-2991aa0a457e | 2025-07-09 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Westminster Pharmaceuticals, LLC | 9dcfc778-5fd6-4c68-8d37-a5385e374617 | 2025-07-08 | Warnings | M001 |
| MGC Health Antacid Soft Chews Cherry Flavor | CALCIUM CARBONATE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3958ec0a-8f32-6918-e063-6294a90ac1c4 | 2025-07-07 | Warnings | M001 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Major Pharmaceuticals | 1bc90fa7-fcce-4a9b-862f-f30ab602ecab | 2025-07-07 | Warnings | M001 |
| KOSHER MEDS antacid | CALCIUM CARBONATE | Mollec Inc | 7783d6a2-56e3-4542-ad1d-60680e03532b | 2025-07-01 | Warnings | M001 |
| Nauzene Chewables Ginger Honey | SODIUM CITRATE | Kobayashi Healthcare International, Inc. | 25c9825d-a4e8-4671-e063-6294a90ab46d | 2025-06-24 | Warnings | M001 |
| Gaviscon Extra Strength | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | Haleon US Holdings LLC | 7f367927-c366-465c-a059-e2cfb337d562 | 2025-06-11 | Warnings | M001 |
| Calmicid AC Acid Reducer | FAMOTIDINE | Melaleuca, Inc. | 369ae213-cd23-57ba-e063-6394a90a87a6 | 2025-06-02 | Warnings | M001 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | American Health Packaging | 2faf291e-1d62-412a-a05e-e992cb7def6a | 2025-05-30 | Warnings | M001 |
| Kids Tummy Relief | CALCIUM CARBONATE | Genexa Inc. | a7831b84-1f51-9258-e053-2a95a90a901e | 2025-05-23 | Warnings | M001 |
| Calcium Carbonate | CALCIUM CARBONATE | Atlantic Biologicals Corps | 38654d22-2f8a-49d2-a1cd-06d341f11323 | 2025-05-12 | 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 |