FDA.reportPublic FDA data

Simethicone

Product NDC
35916-1938
11-digit product format
359161938
Labeler code
35916
Product ID
35916-1938_5d4f98eb-acd2-36a0-e063-6394a90af359
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-28
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Simethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-1938-1Simethicone1000 in 1 BAGCAPSULE, LIQUID FILLED10004
35916-1938-2Simethicone30 in 1 BOTTLECAPSULE, LIQUID FILLED304
35916-1938-3Simethicone2 in 1 BOXCAPSULE, LIQUID FILLED24
35916-1938-3Simethicone1500 in 1 BAGCAPSULE, LIQUID FILLED15004

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN32018302-7ce5-1f15-e063-6394a90ad3784
198852simethicone 125 MG Oral CapsuleSCD32018302-7ce5-1f15-e063-6394a90ad3784
198852dimethicone 125 MG Oral CapsuleSY32018302-7ce5-1f15-e063-6394a90ad3784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-1938-1359161938011000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1938-1) 2025-10-28NoNoCurrent
35916-1938-23591619380230 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1938-2) 2025-10-28NoNoCurrent
35916-1938-3359161938032 BAG in 1 BOX (35916-1938-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG2 bag2026-01-16NoNoCurrent