Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
- Product NDC
- 0904-7557
- 11-digit product format
- 009047557
- Labeler code
- 0904
- Product ID
- 0904-7557_a1959779-7777-44f0-b9bc-2dcab570365e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-07
- Substance
- ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
- Active strength
- 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL
- 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
- Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALUMINUM HYDROXIDE | 1200 mg/30mL |
| DIMETHICONE | 120 mg/30mL |
| MAGNESIUM HYDROXIDE | 1200 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S |
| Rxcui | 307746 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7557-62 | Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | 30 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 30 | | 10 |
| 0904-7557-73 | Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | 10 in 1 TRAY | SUSPENSION | 10 | | 10 |
| 0904-7557-73 | Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | 10 in 1 CASE | SUSPENSION | 10 | | 10 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7557-62 | 00904755762 | 30 mL in 1 CUP, UNIT-DOSE | 30 ml | | | | Historical |
| 0904-7557-73 | 00904755773 | 10 TRAY in 1 CASE (0904-7557-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7557-62) | 10 tray | 2025-07-07 | No | No | Current |