Antacid
- Product NDC
- 68788-8506
- 11-digit product format
- 687888506
- Labeler code
- 68788
- Product ID
- 68788-8506_9370f05c-b940-4db0-abc1-c249264d6008
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- aluminum hydroxide, magnesium hydroxide, simethicone
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- part331
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-06-02
- Substance
- ALUMINUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE
- Active strength
- 400; 40; 400 mg/10mL; mg/10mL; mg/10mL
- 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
- Antacid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALUMINUM HYDROXIDE | 400 mg/10mL |
| DIMETHICONE, UNSPECIFIED | 40 mg/10mL |
| MAGNESIUM HYDROXIDE | 400 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S |
| Rxcui | 307746 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8506-3 | 68788850603 | 355 mL in 1 BOTTLE (68788-8506-3) | 355 ml | 2023-08-15 | No | No | Historical |