NDC 65197-300
Gelusil
Alumina, Magnesia, Simethicone
Gelusil is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Wellspring Pharmaceutical Corporation. The primary component is Aluminum Hydroxide; Magnesium Hydroxide; Dimethicone; Silicon Dioxide.
| Product ID | 65197-300_28803ddd-f231-406f-815a-6c98be2508ff |
| NDC | 65197-300 |
| Product Type | Human Otc Drug |
| Proprietary Name | Gelusil |
| Generic Name | Alumina, Magnesia, Simethicone |
| Dosage Form | Tablet, Chewable |
| Route of Administration | ORAL |
| Marketing Start Date | 2008-09-24 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Labeler Name | WellSpring Pharmaceutical Corporation |
| Substance Name | ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE; SILICON DIOXIDE |
| Active Ingredient Strength | 200 mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 65197-300-10
10 BLISTER PACK in 1 CARTON (65197-300-10) > 10 TABLET, CHEWABLE in 1 BLISTER PACK
| Marketing Start Date | 2008-09-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65197-300-11 [65197030011]
Gelusil TABLET, CHEWABLE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-12-01 |
NDC 65197-300-20 [65197030020]
Gelusil TABLET, CHEWABLE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-07-17 |
| Marketing End Date | 2016-09-30 |
NDC 65197-300-10 [65197030010]
Gelusil TABLET, CHEWABLE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2008-09-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ALUMINUM HYDROXIDE | 200 mg/1 |
OpenFDA Data
| SPL SET ID: | 92fbeec1-1562-40f3-9734-41f133d494f9 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Trademark Results [Gelusil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELUSIL 71427151 0378528 Live/Registered |
William R. Warner & Co., Inc. 1940-01-04 |
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