FDA.reportPublic FDA data

Simethicone

Product NDC
79903-020
11-digit product format
799030020
Labeler code
79903
Product ID
79903-020_2778c24f-cc7a-cf24-e063-6294a90ae5a3
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALMART INC.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-18
Substance
DIMETHICONE
Active strength
250 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
412111Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79a9e0a3-9199-4397-ab29-b8a9c843cdf8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-020-22Simethicone60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-020SIMETHICONE CAPSULE, LIQUID FILLED [WALMART INC.]2Current NDC, Legacy NDC, 1 package rows20241123_79a9e0a3-9199-4397-ab29-b8a9c843cdf8.zip

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 CapsulePSN79a9e0a3-9199-4397-ab29-b8a9c843cdf82
412111simethicone 250 MG Oral CapsuleSCD79a9e0a3-9199-4397-ab29-b8a9c843cdf82
412111dimethicone 250 MG Oral CapsuleSY79a9e0a3-9199-4397-ab29-b8a9c843cdf82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79903-020-227990300202260 CAPSULE, LIQUID FILLED in 1 BOTTLE (79903-020-22) 2020-12-180000-00-00NoNoCurrent