EXTRA STRENGTH GAS RELIEF

Product NDC
57896-694
11-digit product format
578960694
Labeler code
57896
Product ID
57896-694_33da3116-9098-6158-e063-6294a90aed1f
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-01
Substance
DIMETHICONE
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-694-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-694-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-694-03bd6a592717d7…303034d00443…

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
EXTRA STRENGTH GAS RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 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
b6223134-8a2e-d1ec-e053-2995a90a9077Available 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
57896-694-032022-12-15C16284748780-1d6a99b39-9a3e-a426-e053-dadaa90af4c2GC 694
57896-694-032022-01-28C16284748780-1d6a99b39-9a3e-a426-e053-dadaa90af4c2GC 694

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-694-03EXTRA STRENGTH GAS RELIEF30 in 1 BOTTLETABLET, CHEWABLE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-694-03EA - Each57896-694bae3382b-6d54-4397-994d-fc84239fc58a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-694EXTRA STRENGTH GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]3Current NDC, Legacy NDC, 1 package rows20231101_b6223134-8a2e-d1ec-e053-2995a90a9077.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 7 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
application number: M002
Gas-X Ultimate Strength SoftgelsSIMETHICONEHaleon US Holdings LLC24b777e5-f0b5-400d-8ca9-ae0c04b8503b2025-05-20WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
application number: M002
ndc (product): 57896-694
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
application number: M002
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
application number: M002
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
application number: M002
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
application number: M002
Extra Strength Gas Relief Cherry FlavorSIMETHICONEDiscount Drug Mart, Inc2df821f6-e4b5-89ae-e063-6394a90ad4162025-02-24WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEDiscount Drug Mart, Inc2df9117a-97cc-532d-e063-6294a90a1a9c2025-02-20WarningsExact identifier
application number: M002
Alcohol prep padALCOHOL PREP PADTarget Corporationbc9a4f33-3eec-79e3-e053-2a95a90a90172025-02-19WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEBETTER LIVING BRANDS, LLCeb4bef2c-15dd-434a-e053-2a95a90a616f2025-02-12WarningsExact identifier
application number: M002
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c503a99-91da-59f3-e063-6394a90a32ba2025-02-12WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEKROGER COMPANYea1c4aa8-bde6-2072-e053-2995a90a93ba2025-02-10WarningsExact identifier
application number: M002
Gas Relief SIMETHICONE 250 mg Anti-gasSIMETHICONECVS Pharmacy, Inc.63dbc39e-2ba8-4435-9093-d1ad2eb3e8d52025-02-06WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEH E B1894fa42-4aaf-2d17-e063-6394a90a39622025-02-06WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEGuardian Drug Companya5c7c175-1fb7-4b4b-9ba1-b1df1251305c2025-02-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNb6223134-8a2e-d1ec-e053-2995a90a90774
314221simethicone 125 MG Chewable TabletSCDb6223134-8a2e-d1ec-e053-2995a90a90774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-694-035789606940330 TABLET, CHEWABLE in 1 BOTTLE (57896-694-03) 2020-03-010000-00-00NoNoCurrent