ultra strength gas relief

Product NDC: 69452-543
11-digit product format: 694520543
Labeler code: 69452
Product ID: 69452-543_4e6ac4e0-d588-99ea-e063-6394a90a6d29
Type: HUMAN OTC DRUG
Nonproprietary name: simethicone
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: BIONPHARMA INC.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-01
Substance: DIMETHICONE
Active strength: 180 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: ultra strength gas relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	180 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
252294	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
4e6ac834-9ce3-1b54-e063-6294a90a9dff	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-543-83	ultra strength gas relief	300 in 1 BOTTLE	CAPSULE, LIQUID FILLED	300		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 · 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
252294	simethicone 180 MG Oral Capsule	PSN	4e6ac834-9ce3-1b54-e063-6294a90a9dff	1
252294	simethicone 180 MG Oral Capsule	SCD	4e6ac834-9ce3-1b54-e063-6294a90a9dff	1
252294	dimethicone 180 MG Oral Capsule	SY	4e6ac834-9ce3-1b54-e063-6294a90a9dff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-543-83	69452054383	300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-543-83)	2026-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
a+ health-simethicone capsules 180 mg	BIONPHARMA INC. \| Ocean Healthcare Pvt Ltd	2026-04-01	HUMAN OTC DRUG LABEL	1