Over-the-counter drug · OTC MONOGRAPH DRUG

Gas Relief (Simethicone) NDC 51316-597

Dimethicone 125 mg/1 · Capsule, Liquid filled · Oral · CVS PHARMACY, INC

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-597Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0597Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51316-597-1251316059712513160597121 BOTTLE, PLASTIC in 1 BOX (51316-597-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Nov 30, 2023
51316-597-20513160597205131605972072 BLISTER PACK in 1 CARTON (51316-597-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Nov 30, 2023
51316-597-30513160597305131605973030 BLISTER PACK in 1 CARTON (51316-597-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Nov 30, 2023

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)
Gas Relief
Generic name (nonproprietary)
simethicone
Active ingredients
Dimethicone — 125 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
CVS PHARMACY, INCNDC 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 51316-597_37e6d1e0-23cb-4f69-acdf-bfa8b157d16cSPL ID 37e6d1e0-23cb-4f69-acdf-bfa8b157d16cSPL set ID 4ff77b4c-9616-4341-9bf8-eca301345a5fRxCUI 198852UNII 92RU3N3Y1OUPC 0050428140857

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

N451316059712 followed by a unit qualifier and the quantity

Package 51316-0597-12. 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.

Full label on DailyMed (opens in a new tab)

About NDC 51316-597

What is NDC 51316-597?
51316-597 is the product NDC for Gas Relief (simethicone), Dimethicone 125 mg/1 capsule, liquid filled, listed with the FDA by CVS PHARMACY, INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gas Relief (Simethicone).
What is the active ingredient?
Dimethicone.
Who is the labeler?
CVS PHARMACY, INC, 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 Gas Relief?
46 other product NDCs are listed under this name. See all Gas Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Gas Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
gas reliefsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-90972288-0909-65
gas reliefsimethiconeDimethicone 500 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-58169452-0581-24
Gas ReliefDimethicone 125 mg/1CapsuleOralChain Drug Marketing Association, Inc.83324-35283324-0352-30
gas reliefsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-54269452-0542-28
Gas Reliefsimethicone 125 mgDimethicone 125 mg/1Capsule, Liquid filledOralPioneer Life Sciences, LLC72090-06072090-0060-01
Gas Reliefsimethicone 180 mgDimethicone 180 mg/1Capsule, Liquid filledOralPioneer Life Sciences, LLC72090-01572090-0015-01
Gas ReliefsimethiconeDimethicone 125 mg/1CapsuleOralH-E-B37808-74437808-0744-2037808-0744-30
Gas Reliefsimethicone capsules usp, 125 mgDimethicone 125 mg/1Capsule, Liquid filledOralDr. Reddy's Laboratories Inc.75907-36575907-0365-0175907-0365-30
Gas Reliefsimethicone 125 mgDimethicone 125 mg/1Capsule, Liquid filledOralPioneer Life Sciences, LLC72090-01472090-0014-01
Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-32583324-0325-18

All 47 Gas Relief NDCs

Other NDCs under M 002

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 002
ProductStrengthForm · routeLabelerProduct NDC
Extra Strength Gas Relief CherrysimethiconeDimethicone 125 mg/1Tablet, ChewableOralHarris Teeter, LLC69256-134
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0529
Extra Strength Gas ReliefsimethiconeDimethicone, Unspecified 125 mg/1Tablet, ChewableOralSAFEWAY21130-110
Simethicone 250mgDimethicone 250 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-006
FEVIA Gas ControlsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-031
Mylicon Infants Gas Relief OriginalsimethiconeDimethicone 20 mg/.3mLEmulsionOralInfirst Healthcare62372-630
SimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-002
CVS PHARMACY Gas reliefsimethiconeDimethicone, Unspecified 80 mg/1Tablet, ChewableOralCVS51316-111
Curist Gas ReliefsimethiconeDimethicone 180 mg/180mgCapsule, Liquid filledOralLittle Pharma. Inc.72559-041
Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-325
Gas ReliefsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralFamily Dollar (FAMILY WELLNESS)55319-555
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralCare One (Retail Business Services, LLC.)72476-897
Curist Gas ReliefsimethiconeDimethicone 250 mg/250mgCapsule, Liquid filledOralLittle Pharma. Inc.72559-042
mylanta gassimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralInfirst Healthcare62372-554
Ultra Strength Gas ReliefsimethiconeDimethicone 180 mg/1CapsuleOralBETTER LIVING BRANDS, LLC21130-717
SimethiconeDimethicone 80 mg/1Tablet, ChewableOralAphena Pharma Solutions - Tennessee, LLC71610-649
FEVIA Gas ControlsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-031
Mylicon Infants Gas Relief Dye FreesimethiconeDimethicone 20 mg/.3mLEmulsionOralInfirst Healthcare62372-650
QUITA COLICOS Gas RELIEF DropssimethiconeDimethicone 20 mg/.3mLLiquidOralDLC Laboratories, Inc.24286-1533
AntiflatulentsimethiconeDimethicone 80 mg/1Tablet, ChewableOralAphena Pharma Solutions - Tennessee, LLC71610-650

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