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 24 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEHarris Teeter, LLC2c65f7f5-195c-ed33-e063-6294a90a30702025-02-11WarningsExact identifier
application number: M001
Regular Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb50083-b05f-8aca-e063-6394a90a6d6f2025-02-11WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2c544c08-8cdb-edf2-e063-6394a90a024c2025-02-11WarningsExact identifier
application number: M001
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a28a2-f848-d185-e063-6294a90ab3382025-02-07WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.e4b8f068-ad52-10c8-e053-2a95a90a871f2025-02-07WarningsExact identifier
application number: M001
Regular Strength Peppermint AntacidCALCIUM CARBONATEDeMoulas Market Basket89bdb1c0-df39-4c37-bb0d-0bfd0bff85fb2025-02-07WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1cbea7c2-fdc0-5a6b-e063-6294a90a9cfa2025-02-07WarningsExact identifier
application number: M001
Regular Strength AntacidCALCIUM CARBONATEDeMoulas Market Basketbe167e45-3db8-4739-91ac-e83d552236172025-02-07WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a4808-4d0b-783c-e063-6394a90af0c32025-02-07WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATEGuardian Drug Company7f0ca229-7452-4f18-bd2f-bf2dfc3482f82025-02-06WarningsExact identifier
application number: M001
Alkums antacidCALCIUM CARBONATEGuardian Drug Company7451cd9f-1723-46d0-837e-8dc48bfb6bba2025-02-06WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATERetail Business Services, LLC.1e97c054-d6b3-425a-e063-6394a90af8362025-02-04WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.214eed56-2d35-8a69-e063-6394a90a15432025-02-04WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHarris Teeter, LLC2bda25ff-9e56-8f8d-e063-6294a90a6a0f2025-02-04WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.1ea045ae-0b6a-47ae-e063-6394a90a35be2025-02-04WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATERetail Business Services, LLC.214eb054-b7d0-d19f-e063-6394a90a05ba2025-02-04WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERetail Business Services, LLC.1e987226-02fa-9c10-e063-6294a90a83bf2025-02-04WarningsExact identifier
application number: M001
WONDERBELLY MAXIMUM STRENGTH ANTACIDCALCIUM CARBONATEGinger Health Company2969ce5b-39ae-47b7-e063-6394a90a19092025-02-01WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
application number: M001
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
application number: M001