Gas Relief

Product NDC: 36800-122
11-digit product format: 368000122
Labeler code: 36800
Product ID: 36800-122_060e2eb9-d8f8-448f-8db4-928ebac288a9
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Topco Associates, LLC
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-28
Substance: DIMETHICONE
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

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 Relief
Listing expiration: 2026-12-31

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
314221	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
c90d68a0-22e1-4a37-8487-16ecdc431ede	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-122-73	Gas Relief	3 in 1 CARTON	TABLET, CHEWABLE	3		2
36800-122-73	Gas Relief	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-122	GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241228_c90d68a0-22e1-4a37-8487-16ecdc431ede.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
314221	simethicone 125 MG Chewable Tablet	PSN	c90d68a0-22e1-4a37-8487-16ecdc431ede	2
314221	simethicone 125 MG Chewable Tablet	SCD	c90d68a0-22e1-4a37-8487-16ecdc431ede	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-122-73	36800012273	3 BLISTER PACK in 1 CARTON (36800-122-73) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2018-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Extra Strength Gas Relief Tablets	Topco Associates, LLC \| Guardian Drug Company	2024-12-26	Human OTC Drug Label	2