Gas-X

Product NDC: 0067-6275
11-digit product format: 000676275
Labeler code: 0067
Product ID: 0067-6275_0f32f8eb-2579-4a26-99d5-a45c50bf5bdb
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-09-12
Substance: DIMETHICONE, UNSPECIFIED
Active strength: 125 mg/1
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0067-6275	0067-6275-82	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Gas-X
Brand name suffix: Extra Strength Softgels
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE, UNSPECIFIED	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198852	Internal RxNorm lookup
210299	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
fa4a3b07-591b-4445-aa67-b17ba1e67d5c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0067-6275-01	Gas-XExtra Strength Softgels	120 in 1 CARTON	CAPSULE, LIQUID FILLED	120	15
0067-6275-10	Gas-XExtra Strength Softgels	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	15
0067-6275-10	Gas-XExtra Strength Softgels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	15
0067-6275-20	Gas-XExtra Strength Softgels	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	15
0067-6275-20	Gas-XExtra Strength Softgels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	15
0067-6275-30	Gas-XExtra Strength Softgels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	15
0067-6275-30	Gas-XExtra Strength Softgels	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3	15
0067-6275-50	Gas-XExtra Strength Softgels	5 in 1 CARTON	CAPSULE, LIQUID FILLED	5	15
0067-6275-50	Gas-XExtra Strength Softgels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	15
0067-6275-72	Gas-XExtra Strength Softgels	6 in 1 CARTON	CAPSULE, LIQUID FILLED	6	15
0067-6275-72	Gas-XExtra Strength Softgels	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	15
0067-6275-82	Gas-XExtra Strength Softgels	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10	15
0067-6275-82	Gas-XExtra Strength Softgels	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-6275-10	EA - Each	0067-6275	ccc8f669-4f90-41c1-98e4-34f7aec94da3	1	2012-07-24
0067-6275-20	EA - Each	0067-6275	220653e9-beb2-4d77-b763-d523a26130b6	1	2012-07-24
0067-6275-50	EA - Each	0067-6275	90721b79-fb28-4c10-a135-2e906776dc6c	1	2012-07-24
0067-6275-72	EA - Each	0067-6275	515a89ce-10b6-4704-ab16-de6cfefaca92	1	2015-01-05
0067-6275-82	EA - Each	0067-6275	154e27b1-14f2-470e-8039-fe814791321a	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-6275	GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]	15	Current NDC, Legacy NDC, 13 package rows	20250316_fa4a3b07-591b-4445-aa67-b17ba1e67d5c.zip

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 1 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Stomach Relief	CALCIUM CARBONATE	Wal-Mart Stores Inc	7471ec99-6c0b-40d8-a9cf-85240a0d471a	2026-09-09	Warnings	Exact identifier application number: M001
Walgreens Orange Antacid Soft Chew	CALCIUM CARBONATE	Walgreens	5b01be31-5871-d4f5-e063-6294a90a671a	2026-09-08	Warnings	Exact identifier application number: M001
Regular Strength Tropical Fruit	CALCIUM CARBONATE	RARITAN PHARMACEUTICALS INC	38c6cece-71a0-40d8-bfc8-2f6467f9239b	2026-09-05	Warnings	Exact identifier application number: M001
Extra Strength Antacid Assorted Berries	CALCIUM CARBONATE	RARITAN PHARMACEUTICALS INC	07a50168-6b05-4c99-9969-7d7f0aa54f30	2026-09-05	Warnings	Exact identifier application number: M001
DRx CHOICE Antacid Calcium Regular Strength	CALCIUM CARBONATE 500MG	Raritan Pharmaceuticals Inc	0c579405-9397-4bf2-8441-e89011b19ec4	2026-09-05	Warnings	Exact identifier application number: M001
Tums Chewy Bites Wintermint and Vanilla Cream	CALCIUM CARBONATE	Haleon US Holdings LLC	4f094feb-8de1-4ccb-e063-6294a90acec2	2026-09-04	Warnings	Exact identifier application number: M001
DG health Ultra Strength Assorted Fruit Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	98a0503c-add5-4453-9d9d-6f813866f4b3	2026-09-03	Warnings	Exact identifier application number: M001
DG health Ultra Strength Assorted Berry Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	99c7ab95-df12-4041-ae1a-398cc6f0085d	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Ultra Strength	ANTACID TABLETS (CALCIUM CARBONATE)	DOLGENCORP, LLC	e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Liquid Antacid plus Anti Gas	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE	DOLGENCORP, LLC	8ecb4418-e647-49b5-b418-1c63bb3e5a3c	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	4942747a-8b6c-422a-8150-9bd91c0a3778	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Regular Strength	ANTACID TABLETS (CALCIUM CARBONATE)	DOLGENCORP, LLC	13dd2758-a372-4b0e-bc99-56a2dacbf95f	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid Wintergreen flavor	CALCIUM CARBONATE	DOLGENCORP, LLC	b84b3509-3178-4616-9bec-dad85a4f9d2a	2026-09-03	Warnings	Exact identifier application number: M001
DG Health Regular Strength Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	59ad3cc7-4144-442f-a37d-75c5fe23e1ae	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Assorted Fruits Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	112f1002-c007-4363-ade6-8dfbc61f4b64	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid	SMOOTH DISSOLVE CALCIUM CARBONATE	DOLGENCORP, LLC	cabaa8f7-9c93-439d-905a-5ef643a08ea8	2026-09-03	Warnings	Exact identifier application number: M001
Kroger Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	THE KROGER CO.,	175d9f0f-266a-4dc2-865f-d1ebd4ddac51	2026-09-01	Warnings	Exact identifier application number: M001
Kids Antacid	CALCIUM CARBONATE	THE KROGER CO.	d77c629b-5308-4b71-9024-9899cf88dbae	2026-09-01	Warnings	Exact identifier application number: M001
Kroger Extra Strength Smooth Antacid Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	4c8d39d9-9d58-45df-9ffd-2cdc41539c03	2026-09-01	Warnings	Exact identifier application number: M001
Kroger Ultra Strength Assorted Fruit	CALCIUM CARBONATE	KROGER COMPANY	b60ced06-725c-4dae-abbf-21cab9e431f9	2026-08-31	Warnings	Exact identifier application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
210299	Gas-X Extra Strength 125 MG Oral Capsule	PSN	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
198852	simethicone 125 MG Oral Capsule	PSN	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
210299	simethicone 125 MG Oral Capsule [Gas-X]	SBD	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
198852	simethicone 125 MG Oral Capsule	SCD	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
198852	dimethicone 125 MG Oral Capsule	SY	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
210299	Gas-X 125 MG Oral Capsule	SY	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15
210299	Gas-X Extra Strength 125 MG Oral Capsule	SY	fa4a3b07-591b-4445-aa67-b17ba1e67d5c	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-6275-01	00067627501	120 CAPSULE, LIQUID FILLED in 1 CARTON (0067-6275-01)		2017-08-01	0000-00-00	No	No	Current
0067-6275-10	00067627510	1 BLISTER PACK in 1 CARTON (0067-6275-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2011-09-12	0000-00-00	No	No	Current
0067-6275-20	00067627520	2 BLISTER PACK in 1 CARTON (0067-6275-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2011-09-12	0000-00-00	No	No	Current
0067-6275-30	00067627530	3 BLISTER PACK in 1 CARTON (0067-6275-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	3 blister pack	2011-09-12	0000-00-00	No	No	Current
0067-6275-50	00067627550	5 BLISTER PACK in 1 CARTON (0067-6275-50) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	5 blister pack	2011-09-12	0000-00-00	No	No	Current
0067-6275-72	00067627572	6 BLISTER PACK in 1 CARTON (0067-6275-72) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	6 blister pack	2011-09-12	0000-00-00	No	No	Current
0067-6275-82	00067627582	10 in 1 CARTON						Historical