Gas Relief Simethicone 125mg Softgel

Product NDC: 84324-014
11-digit product format: 843240014
Labeler code: 84324
Product ID: 84324-014_5b5f1c15-7b17-42be-b068-804e60596153
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: NUVICARE LLC
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-18
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 Simethicone 125mg Softgel
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
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
b774c8e6-e68e-4a13-834d-7eba34c5c3e0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84324-014-01	Gas Relief Simethicone 125mg Softgel	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84324-014	GAS RELIEF SIMETHICONE 125MG SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [NUVICARE LLC]	1	Current NDC, 1 package rows	20240719_b774c8e6-e68e-4a13-834d-7eba34c5c3e0.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
198852	simethicone 125 MG Oral Capsule	PSN	b774c8e6-e68e-4a13-834d-7eba34c5c3e0	2
198852	simethicone 125 MG Oral Capsule	SCD	b774c8e6-e68e-4a13-834d-7eba34c5c3e0	2
198852	dimethicone 125 MG Oral Capsule	SY	b774c8e6-e68e-4a13-834d-7eba34c5c3e0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84324-014-01	84324001401	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01)	2024-07-18	No	No	Current