FDA.reportPublic FDA data

Simethicone

Product NDC
35916-1940
11-digit product format
359161940
Labeler code
35916
Product ID
35916-1940_5d4f8288-434e-27f8-e063-6394a90a416d
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SOFTGEL HEALTHCARE PRIVATE LIMITED
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-28
Substance
DIMETHICONE
Active strength
250 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
DIMETHICONE250 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-1940-1Simethicone1000 in 1 BAGCAPSULE, LIQUID FILLED10003
35916-1940-2Simethicone10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
35916-1940-2Simethicone5 in 1 CARTONCAPSULE, LIQUID FILLED53

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 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
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
412111simethicone 250 MG Oral CapsulePSN322e6cb3-0ddc-9300-e063-6294a90a972a3
412111simethicone 250 MG Oral CapsuleSCD322e6cb3-0ddc-9300-e063-6294a90a972a3
412111dimethicone 250 MG Oral CapsuleSY322e6cb3-0ddc-9300-e063-6294a90a972a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-1940-1359161940011000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1) 2025-10-28NoNoCurrent
35916-1940-2359161940025 BLISTER PACK in 1 CARTON (35916-1940-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2025-10-28NoNoCurrent