FDA.reportPublic FDA data

Extra Strength Gas Relief

Product NDC
83059-0076
11-digit product format
830590076
Labeler code
83059
Product ID
83059-0076_5a0cad89-765d-b11b-e063-6294a90adfdb
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Shield Pharmaceuticals Corp
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-27
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
534144be-fcaf-400d-b772-595c62ae6ea6Available on FDA.report

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 5 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001
Omeprazole, 24/7 Life by 7-ElevenOMEPRAZOLE TABLET, DELAYED RELEASELil' Drug Store Products, Inc.36d8a272-6cca-e759-e063-6394a90a9df82026-07-08WarningsExact identifier
application number: M001
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLCf4786707-a0f7-4ba8-9656-06278d1b4b6c2026-07-07WarningsExact identifier
application number: M001
Tums UltraCALCIUM CARBONATEHaleon US Holdings LLCc544120f-15f0-48b5-88b2-d4820f180f502026-07-07WarningsExact identifier
application number: M001
Regular Strength Assorted FlavorsANTACID CALCIUM CARBONATEAKRON PHARMA INC3f7fe022-aee9-b899-e063-6394a90afb4e2026-07-07WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEPNP Pharmaceuticals Inc.5103a317-5c4a-ec96-e063-6294a90aad7e2026-07-01WarningsExact identifier
application number: M001
Rolaids MAX STRENGTH 1500CALCIUM CARBONATE, MAGNESIUM HYDROXIDETHE PROCTER & GAMBLE MANUFACTURING COMPANY47f5a78b-66b6-2e09-e063-6294a90a8ad52026-07-01WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATEDOLGENCORP, LLC4d6ebc7e-ef39-47e8-91e9-f38484329fa92026-06-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATE CHEWABLE TABLETSCVS Pharmacy. Inc.24cec2bc-cf12-b513-e063-6394a90a94472026-06-30WarningsExact identifier
application number: M001
Childrens Stomach ReliefCALCIUM CARBONATEChain Drug Marketing Association, Inc.fb47d693-72d7-4586-9855-5e833ad1406f2026-06-18WarningsExact identifier
application number: M001
Dr. Sana Alivio Digestivo UPSET STOMACHEFEFERVESCENT ANTACIDEVI LABS51b8750c-3fcf-2543-e063-6394a90a7a8f2026-06-16WarningsExact identifier
application number: M001
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
application number: M001
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
application number: M001