FDA.reportPublic FDA data

Walgreens

Product NDC
0363-0118
11-digit product format
003630118
Labeler code
0363
Product ID
0363-0118_44698c74-8eef-961f-e063-6394a90ab6a1
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WALGREENS CO.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 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
Walgreens
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 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
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbd2ed5b-14b1-4bdf-bd0a-84579ca3d815Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0118-09WalgreensExtra Strength9 in 1 BOTTLE, PLASTICTABLET, CHEWABLE98
0363-0118-18WalgreensExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE98
0363-0118-18WalgreensExtra Strength2 in 1 CARTONTABLET, CHEWABLE28
0363-0118-48WalgreensExtra Strength4 in 1 CARTONTABLET, CHEWABLE48
0363-0118-48WalgreensExtra Strength12 in 1 BLISTER PACKTABLET, CHEWABLE128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0118WALGREENS EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [WALGREENS CO.]7Current NDC, Legacy NDC, 5 package rows20241110_dbd2ed5b-14b1-4bdf-bd0a-84579ca3d815.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 1 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
application number: M002
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
application number: M002
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
application number: M002
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
application number: M002
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
application number: M002
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
application number: M002
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED322e6cb3-0ddc-9300-e063-6294a90a972a2026-07-31WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
application number: M002
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
application number: M002
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
application number: M002
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
application number: M002
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
application number: M002
Tea Tree Oil AntifungalTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.55a48fc6-1963-66ea-e063-6294a90a35012026-07-02WarningsExact identifier
application number: M002
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
application number: M002
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNdbd2ed5b-14b1-4bdf-bd0a-84579ca3d8158
314221simethicone 125 MG Chewable TabletSCDdbd2ed5b-14b1-4bdf-bd0a-84579ca3d8158

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0118-09003630118099 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0363-0118-09) 2023-05-22NoNoCurrent
0363-0118-18003630118182 BLISTER PACK in 1 CARTON (0363-0118-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-05-150000-00-00NoNoCurrent
0363-0118-48003630118484 BLISTER PACK in 1 CARTON (0363-0118-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2019-05-150000-00-00NoNoCurrent