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 12 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heartburn and gas fruit chewsCALCIUM CARBONATECVS Pharmacy4a656a9f-8f34-69b7-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M001
Orange Antacid Soft ChewCALCIUM CARBONATECVS Pharmacy4a67f0d0-788b-433b-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M001
Cherry Antacid Soft ChewsCALCIUM CARBONATECVS Pharmacy61e4e83c-ee98-579d-e053-2991aa0ab0992025-12-07WarningsExact identifier
application number: M001
CVS Mixed Berry Antacid HBG 54ctCALCIUM CARBONATECVS Pharmacye9204edb-e4d9-3975-e053-2995a90ac6a92025-12-07WarningsExact identifier
application number: M001
CVS Mixed Berry Antacid HBG 28ctCALCIUM CARBONATECVS Pharmacye9481d36-3b28-5caf-e053-2a95a90a31212025-12-07WarningsExact identifier
application number: M001
CVS Wild Berry Antacid ChewsCALCIUM CARBONATECVS Pharmacyf6f45d9c-f9fc-225b-e053-6394a90a30e12025-12-07WarningsExact identifier
application number: M001
CVS Wild Berry Antacid ChewsCALCIUM CARBONATECVS Pharmacyf6f5dc9a-b573-70c1-e053-6394a90acdb02025-12-07WarningsExact identifier
application number: M001
Basic Care Antacid Fruit ChewsCALCIUM CARBONATEAmazon.comc8d2b8aa-fce4-f973-e053-2995a90a6edd2025-12-05WarningsExact identifier
application number: M001
Basic Care Berry Antacid HBGCALCIUM CARBONATEAmazon.comc8d4050e-75fd-2445-e053-2995a90a7b0d2025-12-05WarningsExact identifier
application number: M001
QUALITY CHOICE Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)fce6c50d-908f-44a6-ba63-ece813f3711b2025-12-04WarningsExact identifier
application number: M001
QUALITY CHOICE Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)667ffb59-9bff-45a7-89f0-ccfa0d8419092025-12-04WarningsExact identifier
application number: M001
QUALITY CHOICECALCIUM CARBONATEQUALITY CHOICE (Chain drug Marketing Assoiciation)9ff282fd-7623-4c9e-8faa-c51e33a7616e2025-12-04WarningsExact identifier
application number: M001
QUALITY CHOICE Extra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)7c948dc6-e569-46d2-8edd-59da48857e0e2025-12-04WarningsExact identifier
application number: M001
QUALITY CHOICE Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)b074a885-5d10-46e4-8de9-dd9460968dad2025-12-04WarningsExact identifier
application number: M001
Quality Choice Extra StrengthANTACID TABLETS (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)2bb8ccb6-6275-4ace-8096-ee545501df392025-12-04WarningsExact identifier
application number: M001
Quality Choice Ultra StrengthANTACID TABLET (CALCIUM CARBONATE)QUALITY CHOICE (Chain drug Marketing Assoiciation)cdac56f1-e579-4943-a24a-6564c30086d22025-12-04WarningsExact identifier
application number: M001
QUALITY CHOICE Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.a699b830-6400-4af9-9810-5eda791573332025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Relief PeppermintCALCIUM CARBONATEBayer HealthCare LLC.9b8e802f-91b6-4559-e053-2a95a90aff672025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Cool Action Heartburn Relief MintCALCIUM CARBONATEBayer HealthCare LLC.9b8da147-8d0c-e6b0-e053-2a95a90a35e62025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
application number: M001