FDA.reportPublic FDA data

Extra Strength Gas Relief

Product NDC
83059-0169
11-digit product format
830590169
Labeler code
83059
Product ID
83059-0169_58782a7a-cf73-3719-e063-6394a90a2613
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
2026-08-07
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
55952af9-c3c1-452f-82c8-06f01dc4f0afAvailable 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 23 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2e0d5be6-d41b-cdf8-e063-6394a90a08b42025-02-27WarningsExact identifier
application number: M001
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDEDiscount Drug Mart, Inc2e0a1913-c3d4-7c7d-e063-6294a90a48412025-02-26WarningsExact identifier
application number: M001
Extra Strength sugar free AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2e09f87b-c771-59ae-e063-6294a90a0c392025-02-25WarningsExact identifier
application number: M001
Ultra Strength Antacid Wintergreen FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.409b5d06-3398-4414-8919-10b9064ba4ee2025-02-25WarningsExact identifier
application number: M001
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEDiscount Drug Mart, Inc2df92d5c-cd5a-060b-e063-6394a90aa51f2025-02-25WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEDiscount Drug Mart, Inc2e09cb3b-cf5d-15b1-e063-6394a90a5c6a2025-02-25WarningsExact identifier
application number: M001
Extra Strength Smooth Assorted Fruit AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2df86c35-1e9b-eb49-e063-6294a90aabb62025-02-20WarningsExact identifier
application number: M001
Regular Strength Antacid Regular strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2dfa0de5-6e58-dc9d-e063-6294a90a53e02025-02-20WarningsExact identifier
application number: M001
Childrens Tummy ReliefCALCIUM CARBONATEGenexa Inc.f4d39d3e-82d0-2673-e053-2995a90a7d2a2025-02-20WarningsExact identifier
application number: M001
Extra Strength Smooth Peppermint AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2df8fe2b-cc9a-f026-e063-6394a90aa0ad2025-02-20WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb4ce4e-e18c-c96d-e063-6394a90a18ca2025-02-20WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb60b7e-711a-8052-e063-6394a90acf1d2025-02-20WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2df9e47a-8741-6958-e063-6394a90a6c602025-02-20WarningsExact identifier
application number: M001
Regular Strength Antacid PeppermintCALCIUM CARBONATEDiscount Drug Mart, Inc2e09b8d1-25b4-0e57-e063-6394a90a31e22025-02-20WarningsExact identifier
application number: M001
Tums Chewy Bites Orange and Cream ESCALCIUM CARBONATEHaleon US Holdings LLC036ef1ed-32ef-46b8-8817-b3f63a0142802025-02-14WarningsExact identifier
application number: M001
Tums NaturalsCALCIUM CARBONATEHaleon US Holdings LLCd8da54b8-6456-4e7d-acd2-a55e2249bd012025-02-13WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEHarris Teeter, LLC2cb4c58f-ee88-b60e-e063-6294a90a1e6c2025-02-12WarningsExact identifier
application number: M001
Maximum Strength Antacid CherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c4fc835-a9ad-2666-e063-6394a90a20ac2025-02-12WarningsExact identifier
application number: M001
Maximum Strength AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c5081a6-367f-28bc-e063-6294a90a459e2025-02-12WarningsExact identifier
application number: M001
Regular Strength Antacid PeppermintCALCIUM CARBONATEHarris Teeter, LLC2cb54a40-98ce-2660-e063-6294a90a3ed02025-02-11WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83059-0169-1830590169011 BLISTER PACK in 1 CARTON (83059-0169-1) / 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2026-08-07NoNoCurrent