Over-the-counter drug · OTC MONOGRAPH DRUG

Infants Gas Relief Drops (Simethicone) NDC 49035-709

Dimethicone, Unspecified 20 mg/.3mL · Emulsion · Oral · Wal-Mart Stores,Inc.,

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-709Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0709Add 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
49035-709-0149035070901490350709011 BOTTLE in 1 CARTON (49035-709-01) / 30 mL in 1 BOTTLEMarketed from Oct 16, 2017
49035-709-3049035070930490350709301 BOTTLE in 1 CARTON (49035-709-30) / 30 mL in 1 BOTTLEMarketed from Oct 22, 2019

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)
Infants Gas Relief Drops
Generic name (nonproprietary)
simethicone
Active ingredients
Dimethicone, Unspecified — 20 mg/.3mL
Dosage form
Emulsion
Route
Oral
Labeler
Wal-Mart Stores,Inc.,NDC labeler code 49035
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 49035-709_42223d4a-ac52-c3c5-e063-6394a90a3723SPL ID 42223d4a-ac52-c3c5-e063-6394a90a3723SPL set ID 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157RxCUI 198857UNII 92RU3N3Y1OUPC 0681131769433

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

N449035070901 followed by a unit qualifier and the quantity

Package 49035-0709-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 49035-709

What is NDC 49035-709?
49035-709 is the product NDC for Infants Gas Relief Drops (simethicone), Dimethicone, Unspecified 20 mg/.3mL emulsion, listed with the FDA by Wal-Mart Stores,Inc.,. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Infants Gas Relief Drops (Simethicone).
What is the active ingredient?
Dimethicone, Unspecified.
Who is the labeler?
Wal-Mart Stores,Inc.,, NDC labeler code 49035. 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 Gas Relief Drops?
2 other product NDCs are listed under this name. See all Infants Gas Relief Drops 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 Infants Gas Relief Drops NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Infants Gas Relief DropssimethiconeDimethicone 20 mg/.3mLSuspension/ dropsOralRELIABLE 1 LABORATORIES69618-05969618-0059-51
Infants Gas Relief DropssimethiconeDimethicone, Unspecified 20 mg/.3mLEmulsionOralDOLGENCORP INC55910-79055910-0790-01

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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