Over-the-counter drug · OTC MONOGRAPH DRUG
Infants (Simethicone) NDC 0536-1303
Dimethicone, Unspecified 20 mg/.3mL · Suspension/ drops · Oral · RUGBY LABORATORIES
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1303-75 | 0053613037500536130375 | 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPERMarketed from Sep 1, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Infants
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone, Unspecified — 20 mg/.3mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- RUGBY LABORATORIESNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 002
- Marketing start
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 0536-1303_41f5317f-a058-f03c-e063-6394a90a321aSPL ID 41f5317f-a058-f03c-e063-6394a90a321aSPL set ID c6fa71bc-de48-47f4-80c4-7d92643d2664RxCUI 198857UNII 92RU3N3Y1OUPC 0305361303754
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
N400536130375followed by a unit qualifier and the quantityPackage 00536-1303-75. 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 the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
Excerpt only. Read the full label for complete information.
About NDC 0536-1303
- What is NDC 0536-1303?
- 0536-1303 is the product NDC for Infants (simethicone), Dimethicone, Unspecified 20 mg/.3mL suspension/ drops, listed with the FDA by RUGBY LABORATORIES. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infants (Simethicone).
- What is the active ingredient?
- Dimethicone, Unspecified.
- Who is the labeler?
- RUGBY LABORATORIES, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infants?
- 1 other product NDC are listed under this name. See all Infants NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Infants products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Infantssimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | ATLANTIC BIOLOGICALS CORP. | 17856-1303 | 17856-1303-0117856-1303-0217856-1303-03+2 more |
Other NDCs under M 002
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 |
|---|---|---|---|---|
| Phazymesimethicone | Dimethicone 250 mg/1 | Capsule, Gelatin coatedOral | C.B. Fleet Company, Inc. | 0132-0211 |
| GNP Stomach Reliefbismuth subsalicylate 525 mg | Bismuth subsalicylate 525 mg/30mL | LiquidOral | Amerisource Bergen | 46122-703 |
| EXTRA STRENGTH gas reliefsimethicone | Dimethicone, Unspecified 125 mg/5mL | LiquidOral | KRAMER LABORATORIES | 55505-225 |
| SIMETHICONE INFANT Gas Relief Dropssimethicone | Dimethicone 20 mg/.3mL | SuspensionOral | Atlantic Biologicals Corp. | 17856-1017 |
| good sense gas reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | L. Perrigo Company | 0113-0657 |
| Gencare-Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | PIONEER LIFE SCIENCES, LLC | 72090-073 |
| Simethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALMART INC. | 79903-020 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | KROGER COMPANY | 41226-717 |
| SIMETHICONE INFANT Gas Relief Dropssimethicone | Dimethicone 20 mg/.3mL | SuspensionOral | Atlantic Biologicals Corp. | 17856-1018 |
| GNP Regular Strength Gas Reliefdimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | ATLANTIC BIOLOGICALS CORP. | 17856-1118 |
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 82804-152 |
| basic care gas reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-657 |
| WinCo FOODS Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | WINCO FOODS, LLC | 67091-361 |
| Extra Strength Gas Relief Cherry Flavorsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Discount Drug Mart, Inc | 53943-134 |
| Gas-Aidsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Leosons Overseas Corp | 69626-7197 |
| Extra Strength Gas Reliefsimethicone antigas | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-441 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | H E B | 37808-874 |
| TopCare health EXTRA STRENGTH Gas Relief SOFTGELsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 76162-538 |
| Gas Reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Safeway, Inc. | 21130-446 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
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