FDA.reportPublic FDA data

SIMETHICONE 80MG

Product NDC
77333-812
11-digit product format
773330812
Labeler code
77333
Product ID
77333-812_0e765edc-264e-533a-e063-6394a90a7c53
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-02
Substance
DIMETHICONE
Active strength
80 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct77333-812IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77333-81277333-812-10IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 80MG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 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
314216Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7f470cf-f036-afd9-e053-2995a90a9186Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-812-102024-05-02C16284748780-11030e365-36c0-111a-e063-dadaa90a10e2GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)
77333-812-102024-01-30C16284748780-11030e365-36c0-111a-e063-dadaa90a10e2GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-812-10SIMETHICONE 80MG100 in 1 BOXTABLET, CHEWABLE1006
77333-812-25SIMETHICONE 80MG1 in 1 BLISTER PACKTABLET, CHEWABLE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-812-10EA - Each77333-8122df148c8-f505-4408-8018-d6bad416cded12022-10-06
77333-812-25EA - Each77333-812ef4bf287-d8f8-405e-9c5e-d381af05b35712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-812SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [GENDOSE PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20240504_e7f470cf-f036-afd9-e053-2995a90a9186.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 2 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNe7f470cf-f036-afd9-e053-2995a90a91866
314216simethicone 80 MG Chewable TabletSCDe7f470cf-f036-afd9-e053-2995a90a91866
314216simethicone 80 MG Chewable TabletPSN5e755184-0821-4f92-8f72-84726f7aa4073
314216simethicone 80 MG Chewable TabletSCD5e755184-0821-4f92-8f72-84726f7aa4073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77333-812-1077333081210100 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25) 100 blister pack2022-10-150000-00-00NoNoCurrent
77333-812-25773330812251 in 1 BLISTER PACKHistorical