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 29 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATION9889cf9e-3f6a-4abc-b723-0b295c7c8f932024-10-30WarningsExact identifier
application number: M001
Rite Aid Pharmacy Extra Strength Assorted BerriesCALCIUM CARBONATERITE AID CORPORATIONf697de02-7df9-4419-9835-8b65bbaf42152024-10-29WarningsExact identifier
application number: M001
Premier Value Smooth Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortium0de2c4c5-46fb-4081-aa96-b36794e3983f2024-10-28WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Extra Strength Tropical FruitANTACID TABLETSChain Drug Consortium8999b9c1-05d0-496b-88f2-062908a4fadc2024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortiumef8ab31b-d050-446a-bca9-4a94d4ba17522024-10-25WarningsExact identifier
application number: M001
Premier Value Extra Strength Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEPHARMACY VALUE ALLIANCE, LLCe33db45a-594e-4af8-ab16-10010fc8a3882024-10-25WarningsExact identifier
application number: M001
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
application number: M001
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
application number: M001
PV Extra Strength AntacidCALCIUM CARBONATEPHARMACY VALUE ALLIANCE, LLC8c92de83-ed60-46c3-b289-4b45a1915e242024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Ultra Strength Assorted FruitANTACID TABLETSChain Drug Consortium26c742a7-5806-44e0-bef0-c70a9d77dd232024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Consortium, LLC00a58373-77ab-4a46-9862-d179e17c731a2024-10-25WarningsExact identifier
application number: M001
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
application number: M001
Premier Value Regular Strength Chewable Antacid Peppermint Assorted FruitANTACID TABLETSChain Drug Consortium, LLC245e195f-fd67-497b-83d4-fef75cea8b5b2024-10-25WarningsExact identifier
application number: M001
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
application number: M001
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
application number: M001
Citrus Flavored AntacidCALCIUM CARBONATEJHK DBA American Safety & First Aid79f2b495-a438-408e-9572-b6c3516db52c2024-10-15WarningsExact identifier
application number: M001
NUTRALOXCALCIUM CARBONATEA-S Medication Solutions524e26a9-c69f-4e25-b83d-f4c65adca83d2024-10-11WarningsExact identifier
application number: M001
Mag-AL LiquidALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDEPAI Holdings, LLCb1f2d137-f5f7-4800-a1df-ef5d25544bc92024-10-08WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCbfc78d44-dc90-4f69-85af-a23dd70c68d22024-10-04WarningsExact identifier
application number: M001
HEB Extra Strength sugar free Antacid 174CALCIUM CARBONATEH E B17cd3717-2fc3-1693-e063-6394a90ae03d2024-09-17WarningsExact identifier
application number: M001