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
Ingredient	Strength
DIMETHICONE	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198852	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
534144be-fcaf-400d-b772-595c62ae6ea6	Available 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 20 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Ultra Strength Antacid	CALCIUM CARBONATE	CARDINAL HEALTH 110, LLC. DBA LEADER	eab5a905-67fb-494e-8f55-aeeab4c2dce2	2025-08-22	Warnings	Exact identifier application number: M001
Leader Extra Strength Antacid	CALCIUM CARBONATE	CARDINAL HEALTH 110, LLC. DBA LEADER	81911f6d-7edf-4183-9720-2f20a5db498d	2025-08-21	Warnings	Exact identifier application number: M001
Gas Relief	SIMETHICONE	BJWC (Berkley & Jensen / BJ's)	2f32dde8-502e-eefa-e063-6294a90abf20	2025-08-19	Warnings	Exact identifier application number: M001
CVS Health Ultra Strength Natural Antacid Peppermint Flavor	ANTACID TABLETS	CVS Pharmacy,Inc.	4f18fd8d-4d6a-4b1d-8a94-b64592f73ad0	2025-08-13	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Assorted Berries	CALCIUM CARBONATE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	b84d80c6-0240-4276-8e47-74a918f3d86a	2025-08-12	Warnings	Exact identifier application number: M001
Antacid	CALCIUM CARBONATE	ProStat First Aid	3bb49eb3-2eaa-af8d-e063-6294a90a4035	2025-08-06	Warnings	Exact identifier application number: M001
Maximum Strength Antacid and Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Meijer, Inc.	30a0455d-63e0-95cc-e063-6394a90ada6b	2025-07-30	Warnings	Exact identifier application number: M001
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Menper Distributors Inc.	6efb4da0-03ae-4df6-acd7-e8023d20d4b3	2025-07-22	Warnings	Exact identifier application number: M001
Gas-X Total Relief Maximum Strength	CALCIUM CARBONATE, SIMETHICONE	Haleon US Holdings LLC	edb0f11a-bdb7-484d-9257-09ff47b0fca4	2025-07-15	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	WALGREEN COMPANY	7cd9234e-d1cc-4cce-e053-2991aa0a457e	2025-07-09	Warnings	Exact identifier application number: M001
Sodium Bicarbonate	SODIUM BICARBONATE	Westminster Pharmaceuticals, LLC	9dcfc778-5fd6-4c68-8d37-a5385e374617	2025-07-08	Warnings	Exact identifier application number: M001
MGC Health Antacid Soft Chews Cherry Flavor	CALCIUM CARBONATE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3958ec0a-8f32-6918-e063-6294a90ac1c4	2025-07-07	Warnings	Exact identifier application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	Major Pharmaceuticals	1bc90fa7-fcce-4a9b-862f-f30ab602ecab	2025-07-07	Warnings	Exact identifier application number: M001
KOSHER MEDS antacid	CALCIUM CARBONATE	Mollec Inc	7783d6a2-56e3-4542-ad1d-60680e03532b	2025-07-01	Warnings	Exact identifier application number: M001
Nauzene Chewables Ginger Honey	SODIUM CITRATE	Kobayashi Healthcare International, Inc.	25c9825d-a4e8-4671-e063-6294a90ab46d	2025-06-24	Warnings	Exact identifier application number: M001
Gaviscon Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	Haleon US Holdings LLC	7f367927-c366-465c-a059-e2cfb337d562	2025-06-11	Warnings	Exact identifier application number: M001
Calmicid AC Acid Reducer	FAMOTIDINE	Melaleuca, Inc.	369ae213-cd23-57ba-e063-6394a90a87a6	2025-06-02	Warnings	Exact identifier application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	American Health Packaging	2faf291e-1d62-412a-a05e-e992cb7def6a	2025-05-30	Warnings	Exact identifier application number: M001
Kids Tummy Relief	CALCIUM CARBONATE	Genexa Inc.	a7831b84-1f51-9258-e053-2a95a90a901e	2025-05-23	Warnings	Exact identifier application number: M001
Calcium Carbonate	CALCIUM CARBONATE	Atlantic Biologicals Corps	38654d22-2f8a-49d2-a1cd-06d341f11323	2025-05-12	Warnings	Exact identifier application number: M001