Over-the-counter drug · OTC MONOGRAPH DRUG

Infants Gas relief (Simethicone) NDC 36800-119

Dimethicone 20 mg/.3mL · Solution/ drops · Oral · Topco Associates, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0119Add 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
36800-119-0936800011909368000119091 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPERMarketed from Mar 1, 2013

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
Generic name (nonproprietary)
simethicone
Active ingredients
Dimethicone — 20 mg/.3mL
Dosage form
Solution/ drops
Route
Oral
Labeler
Topco Associates, LLCNDC labeler code 36800
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 36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4aSPL ID edbc1a70-0fe7-42c4-a835-140c9f6aaf4aSPL set ID fd6a2537-8db2-492d-b045-6404df2fb9c3UNII 92RU3N3Y1O

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

N436800011909 followed by a unit qualifier and the quantity

Package 36800-0119-09. 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)

USE(S) relieves the symptoms of 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 36800-119

What is NDC 36800-119?
36800-119 is the product NDC for Infants Gas relief (simethicone), Dimethicone 20 mg/.3mL solution/ drops, listed with the FDA by Topco Associates, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Infants Gas relief (Simethicone).
What is the active ingredient?
Dimethicone.
Who is the labeler?
Topco Associates, LLC, NDC labeler code 36800. 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?
4 other product NDCs are listed under this name. See all Infants 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 Infants Gas relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Infants Gas ReliefsimethiconeDimethicone 20 mg/.3mLSuspensionOralMollec Inc82179-00782179-0007-01
Infants Gas reliefsimethiconeDimethicone 20 mg/.3mLSolution/ dropsOralHarris Teeter, LLC69256-52069256-0520-09
Infants Gas reliefsimethiconeDimethicone 20 mg/.3mLSolution/ dropsOralUNITED NATURAL FOODS, INC. DBA UNFI41163-09641163-0096-09
Infants Gas ReliefsimethiconeDimethicone 20 mg/.3mLSuspensionOralGeri-Care Pharmaceuticals, Corp57896-79857896-0798-01

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 ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralHarris Teeter, LLC69256-135
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0529
Extra Strength Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralGeri-Care Pharmaceuticals, Corp57896-694
QUITA COLICOS Gas RELIEF DropssimethiconeDimethicone 20 mg/.3mLLiquidOralDLC Laboratories, Inc.24286-1533
Gas Relief Extra StrengthsimethiconeDimethicone 125 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-897
Simethicone 80 mgsimethiconeDimethicone 80 mg/1Tablet, ChewableOralProficient Rx LP82804-043
Gas Relief Ultra StrengthsimethiconeDimethicone 180 mg/1Capsule, Liquid filledOralWalgreens0363-8730
gas reliefsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralGLENMARK THERAPEUTICS INC., USA72657-482
SimethiconeDimethicone 250 mg/1Capsule, Liquid filledOralWALGREEN CO.0363-9945
gas reliefsimethiconeDimethicone, Unspecified 125 mg/1Capsule, Liquid filledOralGLENMARK THERAPEUTICS INC., USA72657-480
Target Gas Relief Chews Mixed Berry and StrawberrysimethiconeDimethicone 250 mg/1; Calcium carbonate 750 mg/1Tablet, ChewableOralTarget11673-548
Ultra Strength Gas ReliefsimethiconeDimethicone 180 mg/1CapsuleOralBETTER LIVING BRANDS, LLC21130-717
Simethicone 80MgsimethiconeDimethicone, Unspecified 80 mg/1Tablet, ChewableOralCardinal Health 107, LLC55154-2606
gas reliefsimethiconeDimethicone, Unspecified 180 mg/1Capsule, Liquid filledOralGLENMARK THERAPEUTICS INC., USA72657-481
extra strength Gas Relief cherry cremesimethiconeDimethicone 125 mg/1Tablet, ChewableOralAmerisource Bergen46122-811
Alcohol prep padIsopropyl alcohol 70 g/1001ClothTopicalTarget Corporation11673-139
Maximum Strength Gas ReliefsimethiconeDimethicone, Unspecified 250 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.63868-975
Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralRite Aid Corporation11822-6080
simethicone gas reliefsimethiconeDimethicone 20 mg/.3mLSuspension/ dropsOralMOM Enterprises, LCC71444-788
Gas ReliefsimethiconeDimethicone 125 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-325

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in