Pepto

Product NDC
84126-378
11-digit product format
841260378
Labeler code
84126
Product ID
84126-378_48d6633a-4ef5-aa7a-e063-6294a90ab1d2
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-03
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

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
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314221, 2737528

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-378-16PeptoGas plus Bloating1 in 1 CARTONTABLET, CHEWABLE11
84126-378-16PeptoGas plus Bloating16 in 1 BOTTLE, PLASTICTABLET, CHEWABLE161

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2737528Pepto Gas 125 MG Chewable TabletPSN76fa24d0-731e-4fde-9ad6-c4c890b816b41
314221simethicone 125 MG Chewable TabletPSN76fa24d0-731e-4fde-9ad6-c4c890b816b41
2737528simethicone 125 MG Chewable Tablet [Pepto Gas]SBD76fa24d0-731e-4fde-9ad6-c4c890b816b41
314221simethicone 125 MG Chewable TabletSCD76fa24d0-731e-4fde-9ad6-c4c890b816b41
2737528Pepto Gas 125 MG Chewable TabletSY76fa24d0-731e-4fde-9ad6-c4c890b816b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-378-16841260378161 BOTTLE, PLASTIC in 1 CARTON (84126-378-16) / 16 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2026-03-03NoNoCurrent