mylanta gas

Product NDC: 62372-554
11-digit product format: 623720554
Labeler code: 62372
Product ID: 62372-554_ce925db4-fe1a-4069-96be-ce86cdd4e79a
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Infirst Healthcare
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-29
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: mylanta gas
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
ce925db4-fe1a-4069-96be-ce86cdd4e79a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62372-554-31	mylanta gas	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3		1
62372-554-31	mylanta gas	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		1

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 13 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMETHICONE 80MG	SIMETHICONE	Gendose Pharmaceuticals, LLC	e7f470cf-f036-afd9-e053-2995a90a9186	2024-01-08	Warnings	Exact identifier application number: M002
GAS RELIEF EXTRA STRENGTH	SIMETHICONE	YYBA CORP	cc79435e-6d4b-b283-e053-2995a90a8db3	2024-01-03	Warnings	Exact identifier application number: M002
Childrens Mylicon All in One Tummy Relief for Kids	ANTACID AND ANTIGAS	Infirst Healthcare Inc.	0952eba8-6de2-4a77-956d-339fab437472	2024-01-01	Warnings	Exact identifier application number: M002
Mylicon Infants Gas Relief Original	SIMETHICONE	Infirst Healthcare	395be942-d883-4bcb-8811-6fe1521d5a92	2024-01-01	Warnings	Exact identifier application number: M002
Mylicon Infants Gas Relief Dye Free	SIMETHICONE	Infirst Healthcare	3324139a-ed22-43af-859d-e7af19a24ee9	2024-01-01	Warnings	Exact identifier application number: M002
Mylanta Gas Minis Mint Flavor	SIMETHICONE	Infirst Healthcare Inc.	5045b945-23ee-4c25-a32c-af3cd5045c73	2023-12-04	Warnings	Exact identifier application number: M002
Mylanta Gas Minis Assorted Fruit Flavor	SIMETHICONE	Infirst Healthcare Inc.	c6db9af2-d457-477d-baa9-470ddbba5905	2023-12-04	Warnings	Exact identifier application number: M002
Childrens Mylicon Tummy Relief for Kids	ANTACID AND ANTIGAS	Infirst Healthcare Inc.	432d5b4c-a69b-45f9-b7f0-216726a3eead	2023-12-01	Warnings	Exact identifier application number: M002
INFANTS GAS RELIEF	SIMETHICONE	Geri-Care Pharmaceuticals, Corp	5e08709c-846a-7f13-e053-2991aa0a09a6	2023-11-01	Warnings	Exact identifier application number: M002
GAS RELIEF	SIMETHICONE	STRATEGIC SOURCING SERVICES LLC	ff1fd97c-af4f-dffb-e053-6294a90a2039	2023-10-26	Warnings	Exact identifier application number: M002
INFANT GAS RELIEF	SIMETHICONE	AMERISOURCEBERGEN DRUG CORPORATION	7d3c3cc6-b0a2-620d-e053-2a91aa0a159b	2023-07-18	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Allegiant Health	ae98861e-6a26-4e0e-a66a-b2738d3cbddd	2021-09-24	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Allegiant Health	4c79535c-4372-4fd4-a91a-d93617cd581b	2021-09-24	Warnings	Exact identifier application number: M002
Anti-Gas	SIMETHICONE	Allegiant Health	7731bd63-667e-4fed-b446-92a4a83b66d6	2020-11-03	Warnings	Exact identifier application number: M002
Anti-Gas	SIMETHICONE	Marc Glassman, Inc.	e99f2041-2543-4331-9f54-9eea179f94d2	2020-10-06	Warnings	Exact identifier application number: M002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198852	simethicone 125 MG Oral Capsule	PSN	ce925db4-fe1a-4069-96be-ce86cdd4e79a	1
198852	simethicone 125 MG Oral Capsule	SCD	ce925db4-fe1a-4069-96be-ce86cdd4e79a	1
198852	dimethicone 125 MG Oral Capsule	SY	ce925db4-fe1a-4069-96be-ce86cdd4e79a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62372-554-31	62372055431	3 BLISTER PACK in 1 CARTON (62372-554-31) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	3 blister pack	2026-04-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Infirst Healthcare Inc. Mylanta ® Gas Drug Facts	Infirst Healthcare	2026-05-01	HUMAN OTC DRUG LABEL	1