Simethicone

Product NDC
0363-9945
11-digit product format
003639945
Labeler code
0363
Product ID
0363-9945_27788635-ce7b-f0bb-e063-6394a90abe4b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREEN CO.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-15
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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui412111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9945-02Simethicone1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-9945-02Simethicone12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9945-02EA - Each0363-994535860694-0fbf-4fbc-a2f5-2ec2e3ca1d0312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9945SIMETHICONE CAPSULE, LIQUID FILLED [WALGREEN CO.]3Current NDC, Legacy NDC, 2 package rows20241123_4d523979-e3ae-47e8-9092-00fdffc8bb0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN4d523979-e3ae-47e8-9092-00fdffc8bb0b3
412111simethicone 250 MG Oral CapsuleSCD4d523979-e3ae-47e8-9092-00fdffc8bb0b3
412111dimethicone 250 MG Oral CapsuleSY4d523979-e3ae-47e8-9092-00fdffc8bb0b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9945-02003639945021 BLISTER PACK in 1 CARTON (0363-9945-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-04-150000-00-00NoNoCurrent