Gas Relief Ultra Strength

Product NDC: 53345-003
11-digit product format: 533450003
Labeler code: 53345
Product ID: 53345-003_2752c444-2bca-7d23-e063-6394a90a9c67
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone 180 mg
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-04-15
Substance: DIMETHICONE 410
Active strength: 180 mg/1
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 Ultra Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE 410	180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TYU5GP6XGE	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
2cfb8132-6de4-457d-880b-c870a38862ad	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53345-003-03	Gas Relief Ultra Strength	1 in 1 BOX	CAPSULE, LIQUID FILLED	1		3
53345-003-03	Gas Relief Ultra Strength	25000 in 1 BAG	CAPSULE, LIQUID FILLED	25000		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE 410	ACTIVE INGREDIENT	TYU5GP6XGE	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
DIMETHICONE 410	ACTIVE MOIETY	TYU5GP6XGE	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53345-003	GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	3	Current NDC, Legacy NDC, 2 package rows	20241123_2cfb8132-6de4-457d-880b-c870a38862ad.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 4 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Gas Relief Cherry	SIMETHICONE	Good Sense (Geiss, Destin & Dunn, Inc.)	91f72cf2-297d-48db-8f05-f8a7050d92e8	2026-03-31	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Hyvee Inc	44ea37b1-8cd2-936d-e063-6394a90a2be7	2026-03-27	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Grocery Outlet, Inc.	44672e28-3305-a8cc-e063-6394a90a5fef	2026-03-23	Warnings	Exact identifier application number: M002
gas relief	SIMETHICONE	BIONPHARMA INC.	4d7a9507-6f3c-6d15-e063-6294a90a0160	2026-03-20	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ea6e04dd-4f57-4a88-b269-af38732915b3	2026-03-19	Warnings	Exact identifier application number: M002
SIMETHICONE INFANT Gas Relief Drops	SIMETHICONE	Atlantic Biologicals Corp.	4d658287-358f-d358-e063-6294a90a4bd3	2026-03-19	Warnings	Exact identifier application number: M002
SIMETHICONE INFANT Gas Relief Drops	SIMETHICONE	Atlantic Biologicals Corp.	410d80fc-e55b-08d0-e063-6294a90aba73	2026-03-18	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Walgreens	afcabb34-4ef4-4938-860f-154c204fcd48	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 125 MG	Pioneer Life Sciences, LLC	2c7bac92-4596-40aa-a2f2-4ebe380f1f2f	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 125 MG	Pioneer Life Sciences, LLC	51dc6493-2f9f-4148-be7d-abfef1b25112	2026-03-10	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	TOP CARE (Topco Associates LLC)	ed8a723a-7dac-4670-8f02-f4154e0a36c9	2026-03-02	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Shield Pharmaceuticals Corp	fafb57da-0682-475e-8ff9-17f2182129ef	2026-02-24	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE 180 MG	Pioneer Life Sciences, LLC	f5284b68-f167-41d4-8b2f-ae7bafae0f4c	2026-02-13	Warnings	Exact identifier application number: M002
SFEIXE ANTIFUNGAL PEN	UNDECYLENIC ACID	Zhejiang JOOZENA Medical Technology Co., Ltd.	455ad304-86bc-0abe-e063-6294a90a5b43	2026-02-12	Warnings	Exact identifier application number: M002
Gas Relief Ultimate Strength Softgels	SIMETHICONE	Advanced Rx LLC	5d412711-efd3-4b27-bfde-6fee2f460f8b	2026-02-01	Warnings	Exact identifier application number: M002
Pepto Gas plus Bloating	SIMETHICONE	The Procter & Gamble Manufacturing Company	76fa24d0-731e-4fde-9ad6-c4c890b816b4	2026-01-20	Warnings	Exact identifier application number: M002
QUITA COLICOS Gas RELIEF Drops	SIMETHICONE	DLC Laboratories, Inc.	d4b0fa36-5925-4a6f-b3c9-0c785503976f	2026-01-07	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Safeway, Inc.	7ecfe412-6a58-4dff-a52e-2e02a03426f9	2026-01-05	Warnings	Exact identifier application number: M002
Simethicone 180 MG	SIMETHICONE 180 MG	Farmacias De Similares TX LLC	4b2166f7-8d98-dd76-e063-6394a90a7f0f	2026-01-01	Warnings	Exact identifier application number: M002
Target Gas Relief Chews Mixed Berry and Strawberry	SIMETHICONE	Target	11fd2ccd-3a2b-c141-e063-6394a90ab34f	2025-12-20	Warnings	Exact identifier application number: M002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TYU5GP6XGE	DIMETHICONE 410	9006-65-9	DIMETHICONE 410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	2cfb8132-6de4-457d-880b-c870a38862ad	3
252294	simethicone 180 MG Oral Capsule	SCD	2cfb8132-6de4-457d-880b-c870a38862ad	3
252294	dimethicone 180 MG Oral Capsule	SY	2cfb8132-6de4-457d-880b-c870a38862ad	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53345-003-03	53345000303	1 BAG in 1 BOX (53345-003-03) / 25000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2013-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMETHICONE 180 mg capsule, liquid filled	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	2024-11-20	HUMAN OTC DRUG LABEL	3