What is NDC 35916-1938?

35916-1938 is the product NDC for Simethicone, Dimethicone 125 mg/1 capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.

Softgel Healthcare Pvt Ltd, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Simethicone?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Simethicone NDC 35916-1938 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-1938Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-1938Add 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 NDC	11-digit (billing)	Package
35916-1938-1	35916193801	1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1938-1)Marketed from Oct 28, 2025
35916-1938-2	35916193802	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1938-2)Marketed from Oct 28, 2025
35916-1938-3	35916193803	2 BAG in 1 BOX (35916-1938-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 16, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Simethicone
Generic name (nonproprietary): simethicone
Active ingredients: Dimethicone — 125 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Softgel Healthcare Pvt LtdNDC labeler code 35916
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 002
Marketing start: Oct 28, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 35916-1938_5003982d-9100-ab86-e063-6394a90a83ceSPL ID 5003982d-9100-ab86-e063-6394a90a83ceSPL set ID 32018302-7ce5-1f15-e063-6394a90ad378RxCUI 198852UNII 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

N435916193801 followed by a unit qualifier and the quantity

Package 35916-1938-01. 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 Apr 27, 2026.

Indications (excerpt from the label)

Use 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 35916-1938

What is NDC 35916-1938?: 35916-1938 is the product NDC for Simethicone, Dimethicone 125 mg/1 capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Simethicone.
What is the active ingredient?: Dimethicone.
Who is the labeler?: Softgel Healthcare Pvt Ltd, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Simethicone?: 17 other product NDCs are listed under this name. See all Simethicone 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 Simethicone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Simethicone	Dimethicone 500 mg/1	Capsule, Liquid filledOral	SOFTGEL HEALTHCARE PRIVATE LIMITED	35916-1942	35916-1942-01
Simethiconetarget berry blast antacid hbg chew	Dimethicone 80 mg/1; Calcium carbonate 750 mg/1	Tablet, ChewableOral	Target	11673-549	11673-0549-60
Simethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	YYBA	73581-302	73581-0302-36
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	SOFTGEL HEALTHCARE PRIVATE LIMITED	35916-1940	35916-1940-0135916-1940-02
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	AMZ789 LLC	73629-002	73629-0002-18
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALMART INC.	79903-020	79903-0020-22
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALGREEN CO.	0363-9945	00363-9945-02
Simethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-036	53345-0036-01
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	53345-032	53345-0032-02
Simethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	53345-033	53345-0033-01

All 18 Simethicone 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
Product	Strength	Form · route	Labeler	Product NDC
Alcohol prep pad	Isopropyl alcohol 70 g/1001	ClothTopical	Target Corporation	11673-139
Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone	Aluminum hydroxide 400 mg/5mL + 2 more ingredients	SuspensionOral	American Health Packaging	60687-888
Amazon Extra Strengthsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	AMAZON.COM SERVICES LLC	72288-101
Antacid Antigasaluminum hydroxide, magnesium hydroxide, simethicone	Aluminum hydroxide 400 mg/10mL + 2 more ingredients	LiquidOral	Retail Business Services, LLC.	72476-503
Anti-Gassimethicone	Dimethicone 125 mg/1	CapsuleOral	Marc Glassman, Inc.	68998-419
Anti-Gassimethicone	Dimethicone 125 mg/1	CapsuleOral	Allegiant Health	69168-419
Anti-Gas Stripsimethicone	Dimethicone 62.5 mg/1	StripOral	Calmour	82918-001
Anti-Gas Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-773
Antiflatulentsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Major Pharmaceuticals	0904-7206
Antiflatulentsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Aphena Pharma Solutions - Tennessee, LLC	71610-650
basic care gas reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-428
basic care gas reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-657
Best Choicesimethicone	Dimethicone, Unspecified 20 mg/.3mL	Suspension/ dropsOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-709
Best Choice Extra Strengthsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-110
Cardinal Health Infants Gas Reliefsimethicone	Dimethicone, Unspecified 20 mg/.3mL	Suspension/ dropsOral	CARDINAL HEALTH	70000-0051
Care One Gas Reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	American Sales Company	41520-657
Childrens Emetrol Multi Symptom Upset Stomach Reliefchildrens emetrol multi-symptom upset stomach relief	Calcium cation 400 mg/1; Dimethicone 40 mg/1	Tablet, ChewableOral	WellSpring Pharmaceutical Corporation	65197-230
Childrens Mylicon All in One Tummy Relief for Kidsantacid and antigas	Calcium carbonate 400 mg/5mL; Dimethicone 40 mg/5mL	LiquidOral	Infirst Healthcare Inc.	62372-410
Childrens Mylicon Tummy Relief for Kidsantacid and antigas	Calcium carbonate 400 mg/1; Dimethicone 40 mg/1	Tablet, ChewableOral	Infirst Healthcare Inc.	62372-400
Childrens Simethicone Drops	Dimethicone 40 mg/.6mL	LiquidOral	PAI Holdings, LLC dba PAI Pharma	0121-1095

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