Over-the-counter drug · OTC MONOGRAPH DRUG
CVS PHARMACY Extra Strength (Simethicone) NDC 51316-110
Dimethicone, Unspecified 125 mg/1 · Tablet, Chewable · Oral · CVS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-110-00 | 5131601100051316011000 | 100 TABLET, CHEWABLE in 1 CARTON (51316-110-00)Marketed from Oct 23, 2023 | |
| 51316-110-18 | 5131601101851316011018 | 2 BLISTER PACK in 1 CARTON (51316-110-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 5, 2021 |
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)
- CVS PHARMACY Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone, Unspecified — 125 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- CVSNDC labeler code 51316
- 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 51316-110_ae481994-9f88-49b2-b56a-7bfb66f3d7a5SPL ID ae481994-9f88-49b2-b56a-7bfb66f3d7a5SPL set ID 98db6216-897c-4cf6-a4b7-b913ae3a2496RxCUI 314221UNII 92RU3N3Y1OUPC 0050428414927
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
N451316011000followed by a unit qualifier and the quantityPackage 51316-0110-00. 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 For the relief of ▪ pressure, bloating and fullness commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 51316-110
- What is NDC 51316-110?
- 51316-110 is the product NDC for CVS PHARMACY Extra Strength (simethicone), Dimethicone, Unspecified 125 mg/1 tablet, chewable, listed with the FDA by CVS. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CVS PHARMACY Extra Strength (Simethicone).
- What is the active ingredient?
- Dimethicone, Unspecified.
- Who is the labeler?
- CVS, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CVS PHARMACY Extra Strength?
- 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 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 |
|---|---|---|---|---|
| Extra Strength Gas Relief Cherrysimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-134 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-110 |
| Simethicone 250mg | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-006 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Originalsimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-630 |
| Simethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-002 |
| CVS PHARMACY Gas reliefsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | CVS | 51316-111 |
| Curist Gas Reliefsimethicone | Dimethicone 180 mg/180mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-041 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-555 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-897 |
| Curist Gas Reliefsimethicone | Dimethicone 250 mg/250mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-042 |
| mylanta gassimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Infirst Healthcare | 62372-554 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-649 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Dye Freesimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-650 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-650 |
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