Extra Strength Gas Relief

Product NDC
85828-722
11-digit product format
858280722
Labeler code
85828
Product ID
85828-722_4db0a517-b466-216f-e063-6394a90aece0
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE
Route
ORAL
Labeler
Grocery Outlet, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-25
Substance
DIMETHICONE
Active strength
125 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
Extra Strength Gas Relief
Listing expiration
2027-12-31

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
198852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44672e28-3305-a8cc-e063-6394a90a5fefAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-722-30Extra Strength Gas Relief15 in 1 BLISTER PACKCAPSULE152
85828-722-30Extra Strength Gas Relief2 in 1 CARTONCAPSULE22

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 9 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
application number: M002
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI5dae8bbe-219b-4aa1-bf7f-6471fa2856d92024-12-20WarningsExact identifier
application number: M002
GNP Stomach ReliefBISMUTH SUBSALICYLATE 525 MGAmerisource Bergenead13b6b-de37-49f9-b18e-68096651d47e2024-12-20WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFIa9902ba0-f239-4e66-8d66-7cef39a5fdc32024-12-20WarningsExact identifier
application number: M002
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergena6ed50d5-574f-4d6b-be48-e146593389932024-12-20WarningsExact identifier
application number: M002
WinCo Foods Gas Relief Extra Strength SoftgelsSIMETHICONEWinCo Foods, LLCa1a19ef7-4a14-4fcb-8917-631d867be0bb2024-12-18WarningsExact identifier
application number: M002
Discount Drugmart Gas Relief Extra Strength SoftgelsSIMETHICONEDiscount Drug Mart, Inc63f3e5f0-10da-4681-a4f1-8ca1eb7e390f2024-12-18WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association06dfb541-fd1f-4cee-a4a6-44252f1f65a02024-12-18WarningsExact identifier
application number: M002
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
application number: M002
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthDIMETHICONETOPCO ASSOCIATES LLCb9a4c876-722b-4d6c-807f-005ccf5df3202024-12-14WarningsExact identifier
application number: M002
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
application number: M002
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
application number: M002
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd0c9c5fec-ddd4-41a5-8ff9-6b55c376dd362024-11-25WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.f7c40b12-11e4-4b85-afb2-0ea33e4f218c2024-11-25WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN44672e28-3305-a8cc-e063-6394a90a5fef2
198852simethicone 125 MG Oral CapsuleSCD44672e28-3305-a8cc-e063-6394a90a5fef2
198852dimethicone 125 MG Oral CapsuleSY44672e28-3305-a8cc-e063-6394a90a5fef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85828-722-30858280722302 BLISTER PACK in 1 CARTON (85828-722-30) / 15 CAPSULE in 1 BLISTER PACK2 blister pack2026-03-25NoNoCurrent