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 |
|---|---|---|---|---|---|---|
| Goodsense Extra Strength Antacid | CALCIUM CARBONATE | GoodSense | 193a1805-9f57-29cd-e063-6394a90ab99f | 2024-09-13 | Warnings | M001 |
| QCH Maximum Strength Antacid 516 | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Chain Drug Marketing Association Inc. | 1794c35a-79c5-48c2-e063-6394a90a6d29 | 2024-08-28 | Warnings | M001 |
| QCH Regular Strength Antacid 509 | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Chain Drug Marketing Association Inc. | 17947ccd-6f11-d4cd-e063-6294a90a108a | 2024-08-27 | Warnings | M001 |
| Regular Strength Antacid Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Chain Drug Marketing Association Inc. | 17dfe539-923b-e623-e063-6294a90a041f | 2024-08-27 | Warnings | M001 |
| QCH Extra Strength Gas Relief Cherry Flavor 134CHR | SIMETHICONE | Chain Drug Marketing Association Inc. | 17e3300c-3d31-b7e1-e063-6294a90af082 | 2024-08-27 | Warnings | M001 |
| Quality Choice Infants Non-staining Gas relief | SIMETHICONE | Chain Drug Marketing Association Inc. | 17e181e5-6527-54d0-e063-6294a90addc2 | 2024-08-23 | Warnings | M001 |
| Tums Chewy Bites | CALCIUM CARBONATE | Haleon US Holdings LLC | 72ac000c-90f7-42e2-88a6-740de114a954 | 2024-08-21 | Warnings | M001 |
| GDC Extra strength Alkums Antacid 127AF | CALCIUM CARBONATE | Guardian Drug Company | 1b6da4a3-cfa6-6d98-e063-6394a90a5889 | 2024-08-13 | Warnings | M001 |
| Wonderbelly Maximum Strength Antacid - Sweet Mint | CALCIUM CARBONATE | Ginger Health Company | 17ddf76b-237a-eeee-e063-6294a90ac205 | 2024-07-29 | Warnings | M001 |
| Good Neighbor Pharmacy Antacid Regular Strength | CALCIUM CARBONATE | AmerisourceBergen Drug Corporation | 2847e82e-203e-4976-8c4f-4a5caa75ce00 | 2024-07-09 | Warnings | M001 |
| Kirkland Ultra Stregth Antacid 171AB | CALCIUM CARBONATE | COSTCO WHOLESALE COMPANY | 1bea92e8-1b94-77b0-e063-6394a90a8212 | 2024-07-08 | Warnings | M001 |
| ANTACID AND GASRELIEF | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | GOODSENSE | a951fa64-7775-470e-e053-2995a90aefc4 | 2024-06-10 | Warnings | M001 |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | NuCare Pharmaceuticals,Inc. | 5b1f4c78-d42e-32c7-e053-2991aa0a1985 | 2024-06-04 | Warnings | M001 |
| Mylanta All-Family Multi Symptom Stomach Remedy | CALCIUM CARBONATE, SIMETHICONE | Infirst Healthcare Inc. | 19118884-2016-e86e-e063-6294a90a370c | 2024-05-22 | Warnings | M001 |
| Stomach Circle K | BISMUTH SUBSALICYLATE | Lil' Drug Store Products, Inc | 05e14009-b35d-4711-b6f0-89b6d060b387 | 2024-05-06 | Warnings | M001 |
| Tums Chewy Bites Peppermint | CALCIUM CARBONATE | Haleon US Holdings LLC | 45a44b2b-1633-49c5-8c55-9e9af3545c92 | 2024-05-03 | Warnings | M001 |
| MINT ANTACID 100 | CALCIUM CARBONATE | JHK Inc dba American Safety & First Aid | 2496aed6-68ec-44c4-afc9-f7fa41b2147b | 2024-04-24 | Warnings | M001 |
| Tums Chewy Bites Assorted Berries | CALCIUM CARBONATE | Navajo Manufacturing Company Inc. | 1625c724-7ead-cc70-e063-6294a90aa558 | 2024-04-15 | Warnings | M001 |
| Gas-X Maximum Strength Softgels | SIMETHICONE | Haleon US Holdings LLC | 45d1e373-0717-47df-9160-619c451666f4 | 2024-04-05 | Warnings | M001 |
| Gas-X Total Relief Maximum Strength | CALCIUM CARBONATE, SIMETHICONE | Haleon US Holdings LLC | 62fc0a91-c44f-4546-a472-c183a2d95486 | 2024-04-05 | 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 |