Over-the-counter drug · OTC MONOGRAPH DRUG
Gelusil (Alumina, magnesia, simethicone) NDC 65197-300
Aluminum hydroxide 200 mg/1 + 3 more ingredients · Tablet, Chewable · Oral · WellSpring Pharmaceutical Corporation
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65197-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65197-0300Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65197-300-10 | 6519703001065197030010 | 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 24, 2008 | |
| 65197-300-11 | 6519703001165197030011 | 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)Marketed from Dec 1, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gelusil
- Generic name (nonproprietary)
- alumina, magnesia, simethicone
- Active ingredients
- Aluminum hydroxide — 200 mg/1Magnesium hydroxide — 200 mg/1Dimethicone, Unspecified — 24 mg/1Silicon dioxide — 1 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- WellSpring Pharmaceutical CorporationNDC labeler code 65197
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 001
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Skin Barrier Activity (Physiologic effect)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101SPL ID 4406bf6b-b261-c6e1-e063-6294a90ae101SPL set ID 92fbeec1-1562-40f3-9734-41f133d494f9RxCUI 211633, 307747UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O, ETJ7Z6XBU4UPC 0365197300112
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465197030010followed by a unit qualifier and the quantityPackage 65197-0300-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Relieves: Heartburn Sour stomach Acid indigestion Bloating, pressure and discomfort commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 65197-300
- What is NDC 65197-300?
- 65197-300 is the product NDC for Gelusil, Aluminum hydroxide 200 mg/1 + 3 more ingredients tablet, chewable, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gelusil (Alumina, Magnesia, Simethicone).
- What is the active ingredient?
- Aluminum hydroxide, Magnesium hydroxide, Dimethicone, Unspecified, Silicon dioxide.
- Who is the labeler?
- WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gelusil?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 001
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acid Gone Antacidaluminum hydroxide and magnesium carbonate | Aluminum hydroxide 95 mg/15mL; Magnesium carbonate 358 mg/15mL | LiquidOral | Major Pharmaceuticals | 0904-7727 |
| Acid Gone Antacid Extra Strengthaluminum hydroxide and magnesium carbonate | Aluminum hydroxide 160 mg/1; Magnesium carbonate 105 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-5365 |
| ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozsodium bicarbonate | Sodium bicarbonate 315 mg/g | PowderOral | Evi Labs | 84178-106 |
| Advanced Antacid Mintaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 400 mg/10mL + 2 more ingredients | SuspensionOral | GOODSENSE | 50804-639 |
| Advanced Regular Strength Antacidaluminum hydroxide, magnesium hydroxide, simethicone | Aluminum hydroxide 200 mg/5mL + 2 more ingredients | SuspensionOral | WALGREEN COMPANY | 0363-1639 |
| Alka-Seltzer Cool Action Extra Strength ReliefChews Mintcalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0058 |
| Alka-Seltzer Cool Action Heartburn Relief Mintcalcium carbonate | Calcium carbonate 750 mg/1 | Gum, ChewingOral | Bayer HealthCare LLC. | 0280-0001 |
| Alka-Seltzer Extra Strengthanhydrous citric acid, sodium bicarbonate, and aspirin | Anhydrous citric acid 1000 mg/1 + 2 more ingredients | Granule, EffervescentOral | Bayer HealthCare LLC. | 0280-0211 |
| Alka-Seltzer Extra Strength Heartburn ReliefChewscalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0042 |
| Alka-Seltzer Gold | Citric acid monohydrate 1000 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-4100 |
| Alka-Seltzer Heartburnanhydrous citric acid, sodium bicarbonate (heat-treated) | Citric acid monohydrate 1000 mg/1; Sodium bicarbonate 1940 mg/1 | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-0047 |
| Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punchcalcium carbonate and simethicone | Dimethicone 80 mg/1; Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0225 |
| Alka-Seltzer Heartburn Relief Extra Strengthanhydrous citric acid, sodium bicarbonate (heat-treated) | Sodium bicarbonate 1976 mg/1; Citric acid monohydrate 1000 mg/1 | Tablet, EffervescentOral | Bayer Healthcare LLC | 0280-0079 |
| Alka-Seltzer Heartburn Relief Lemon Limeanhydrous citric acid, sodium bicarbonate (heat-treated) | Sodium bicarbonate 1650 mg/1; Citric acid monohydrate 1000 mg/1 | Tablet, EffervescentOral | Bayer Healthcare LLC | 0280-0083 |
| Alka-Seltzer Heartburn Relief Peppermintcalcium carbonate | Calcium carbonate 750 mg/1 | Gum, ChewingOral | Bayer HealthCare LLC. | 0280-0002 |
| Alka-Seltzer Heartburn ReliefChewscalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0221 |
| Alka-Seltzer Heartburn ReliefChews Strawberry and Orangecalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0224 |
| Alka-Seltzer Kids Tummy ReliefChewscalcium carbonate and dimethicone | Calcium carbonate 750 mg/1; Dimethicone 80 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0051 |
| Alka-Seltzer Ultra Strength Heartburn ReliefChewscalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0245 |
| Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and Orangecalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 0280-0059 |
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