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; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE; SILICON DIOXIDE
- Active strength
- 200; 24; 200; 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
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 |
| DIMETHICONE, UNSPECIFIED | 24 mg/1 |
| MAGNESIUM HYDROXIDE | 200 mg/1 |
| SILICON DIOXIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S, ETJ7Z6XBU4 |
| Rxcui | 211633, 307747 |
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 |
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 |