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		2026-10-16

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 5 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FEVIA Acid Control	CALCIUM CARBONATE	VIVUNT PHARMA LLC	4d695a90-6502-3020-e063-6394a90ab0c3	2026-07-15	Warnings	Exact identifier application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	Amerisource Bergen	5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f	2026-07-13	Warnings	Exact identifier application number: M001
Major Regular Strength Assorted Flavors	ANTACID TABLETS	Major Pharmaceuticals	2ba0eeb2-7048-4259-83d5-9f4ec1c92d32	2026-07-13	Warnings	Exact identifier application number: M001
Good Neighbor Extra Strength Assorted Fruits	CALCIUM CARBONATE	AMERISOURCE BERGEN	abf564a1-0823-433d-a023-8be4e085daf4	2026-07-13	Warnings	Exact identifier application number: M001
Omeprazole, 24/7 Life by 7-Eleven	OMEPRAZOLE TABLET, DELAYED RELEASE	Lil' Drug Store Products, Inc.	36d8a272-6cca-e759-e063-6394a90a9df8	2026-07-08	Warnings	Exact identifier application number: M001
Tums Ultra	CALCIUM CARBONATE	Haleon US Holdings LLC	c544120f-15f0-48b5-88b2-d4820f180f50	2026-07-07	Warnings	Exact identifier application number: M001
Regular Strength Assorted Flavors	ANTACID CALCIUM CARBONATE	AKRON PHARMA INC	3f7fe022-aee9-b899-e063-6394a90afb4e	2026-07-07	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Westminster Pharmaceuticals, LLC	52eeac0e-94bb-48c3-81dc-578e96406c01	2026-07-06	Warnings	Exact identifier application number: M001
Kids Tummy Relief	CALCIUM CARBONATE	PNP Pharmaceuticals Inc.	5103a317-5c4a-ec96-e063-6294a90aad7e	2026-07-01	Warnings	Exact identifier application number: M001
Childrens Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	4d6ebc7e-ef39-47e8-91e9-f38484329fa9	2026-06-30	Warnings	Exact identifier application number: M001
Ultra Strength Antacid	CALCIUM CARBONATE CHEWABLE TABLETS	CVS Pharmacy. Inc.	24cec2bc-cf12-b513-e063-6394a90a9447	2026-06-30	Warnings	Exact identifier application number: M001
Childrens Stomach Relief	CALCIUM CARBONATE	Chain Drug Marketing Association, Inc.	fb47d693-72d7-4586-9855-5e833ad1406f	2026-06-18	Warnings	Exact identifier application number: M001
Dr. Sana Alivio Digestivo UPSET STOMACH	EFEFERVESCENT ANTACID	EVI LABS	51b8750c-3fcf-2543-e063-6394a90a7a8f	2026-06-16	Warnings	Exact identifier application number: M001
E-Z-GAS II	ANTACID/ANTIFLATULENT	E-Z-EM, INC.	4e12e1cb-b033-076d-e054-00144ff8d46c	2026-06-15	Warnings	Exact identifier application number: M001
Sodium Bicarbonate	SODIUM BICARBONATE	Cardinal Health 107, LLC	60c2a176-8854-4479-b853-d07fe9a1830c	2026-06-12	Warnings	Exact identifier application number: M001
Mag-Al Plus	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	Cardinal Health 107, LLC	08df7403-9ee3-4a43-a151-c1a6ef7a7549	2026-06-10	Warnings	Exact identifier application number: M001
Childrens Antacid	CALCIUM CARBONATE	Rite Aid Corporation	d09c2d99-9a1f-4eae-a048-ab6dbf74a798	2026-06-09	Warnings	Exact identifier application number: M001
Maximum Strength Calcium Carbonate 1000mg	CALCIUM CARBONATE CHEWABLE TABLETS	CVS HEALTH CORP	24ce4597-b571-3cbf-e063-6394a90a8ea2	2026-06-09	Warnings	Exact identifier application number: M001
Tums Chewy Bites with Gas Relief	CALCIUM CARBONATE AND SIMETHICONE	Haleon US Holdings LLC	6d7be7e4-4bff-4cfd-bbbe-df412ac9db10	2026-06-09	Warnings	Exact identifier application number: M001
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa	2026-06-04	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