FDA.reportPublic FDA data

ultra strength gas relief

Product NDC
69452-543
11-digit product format
694520543
Labeler code
69452
Product ID
69452-543_4e6ac4e0-d588-99ea-e063-6394a90a6d29
Type
HUMAN OTC DRUG
Nonproprietary name
simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
DIMETHICONE
Active strength
180 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
ultra strength gas relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 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
252294Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e6ac834-9ce3-1b54-e063-6294a90a9dffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-543-83ultra strength gas relief300 in 1 BOTTLECAPSULE, LIQUID FILLED3001

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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
application number: M002
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
application number: M002
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN4e6ac834-9ce3-1b54-e063-6294a90a9dff1
252294simethicone 180 MG Oral CapsuleSCD4e6ac834-9ce3-1b54-e063-6294a90a9dff1
252294dimethicone 180 MG Oral CapsuleSY4e6ac834-9ce3-1b54-e063-6294a90a9dff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-543-8369452054383300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-543-83) 2026-04-01NoNoCurrent