FDA.reportPublic FDA data

Pepto

Product NDC
84126-368
11-digit product format
841260368
Labeler code
84126
Product ID
84126-368_5d1b5519-3e9b-d5ec-e063-6394a90a60d0
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
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
Pepto
Brand name suffix
Gas plus Bloating
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
84126-368-24PeptoGas plus Bloating24 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED241
84126-368-24PeptoGas plus Bloating1 in 1 CARTONCAPSULE, LIQUID FILLED11
84126-368-50PeptoGas plus Bloating50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED501
84126-368-50PeptoGas plus Bloating1 in 1 CARTONCAPSULE, LIQUID FILLED11

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 CapsulePSN3d80a5bb-0ed0-769a-e063-6394a90ac50c1
412111simethicone 250 MG Oral CapsuleSCD3d80a5bb-0ed0-769a-e063-6394a90ac50c1
412111dimethicone 250 MG Oral CapsuleSY3d80a5bb-0ed0-769a-e063-6394a90ac50c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-368-24841260368241 BOTTLE, PLASTIC in 1 CARTON (84126-368-24) / 24 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2026-03-02NoNoCurrent
84126-368-50841260368501 BOTTLE, PLASTIC in 1 CARTON (84126-368-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2025-10-01NoNoCurrent