Simethicone 125 mg

Product NDC: 17856-0137
11-digit product format: 178560137
Labeler code: 17856
Product ID: 17856-0137_38930d1f-1f60-1fa5-e063-6394a90a5c21
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-04-25
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0137-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0137-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0137-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0137-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0137-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0137-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0137-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0137-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0137-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0137-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0137-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0137-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0137-1	`1332a3947898…`	`d4bfe170f9cd…`

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: Simethicone 125 mg
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
4ce98db3-c7a6-4627-88c5-9de302a53188	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0137-1	2025-04-03	C162847	48780-1	1030e364-fccf-111a-e063-dadaa90a10e2	Simethicone 125 mg
17856-0137-1	2024-01-30	C162847	48780-1	1030e364-fccf-111a-e063-dadaa90a10e2	Simethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0137-1	Simethicone 125 mg	100 in 1 BOX, UNIT-DOSE	TABLET, CHEWABLE	100	4
17856-0137-1	Simethicone 125 mg	1 in 1 POUCH	TABLET, CHEWABLE	1	4
17856-0137-2	Simethicone 125 mg	1 in 1 POUCH	TABLET, CHEWABLE	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0137	SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [ATLANTIC BIOLOGICALS CORP.]	3	Current NDC, Legacy NDC, 3 package rows	20250406_4ce98db3-c7a6-4627-88c5-9de302a53188.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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	346df37d-b0fc-4fa5-8c19-492fed58c239	2024-11-25	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief Cherry	SIMETHICONE	Retail Business Services, LLC.	1e8ed36d-5236-163b-e063-6294a90ad6ec	2024-11-22	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	0f9639fa-e1d0-460d-bc46-714a01cd9811	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	852cec3b-6564-46b2-afe5-ecef31424237	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Walgreen Co.	d33e413d-4add-459f-ba46-c23b49cfcc87	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Walgreen Co.	d87a20d4-dd1d-4897-9321-f81df2cfbcc7	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Walgreen Co.	b14b647f-d729-47df-879d-ca08a30b995e	2024-11-21	Warnings	Exact identifier application number: M002
Ultra Strength Gas Relief	SIMETHICONE	Wal-Mart Stores Inc	206d57ec-c854-496e-af53-7d8b2a208d85	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	WALGREEN CO.	4d523979-e3ae-47e8-9092-00fdffc8bb0b	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Wal-Mart Stores Inc	69351cf9-3092-45ca-8b84-83e3737fa8d4	2024-11-21	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	WALMART INC.	79a9e0a3-9199-4397-ab29-b8a9c843cdf8	2024-11-21	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief	SIMETHICONE	FOODHOLD U.S.A., LLC	c37def6e-bb10-41ba-8bce-b06c09edbe9f	2024-11-21	Warnings	Exact identifier application number: M002
Gas Relief Ultra Strength	SIMETHICONE 180 MG	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	2cfb8132-6de4-457d-880b-c870a38862ad	2024-11-20	Warnings	Exact identifier application number: M002
Gas-Aid	SIMETHICONE	Leosons Overseas Corp	d271bfcb-bf13-4a97-bc03-f1824826f15a	2024-11-19	Warnings	Exact identifier application number: M002
Gas-Aid Drops for infants	SIMETHICONE	Leosons Overseas Corp	06665701-5f1c-4f8f-8775-e0a4a9ef2029	2024-11-19	Warnings	Exact identifier application number: M002
Mag-AL Plus XS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE	PAI Holdings, LLC dba PAI Pharma	db0c47ab-5296-4195-9fa6-2e338b665094	2024-11-12	Warnings	Exact identifier application number: M002
basic care gas relief	SIMETHICONE	Amazon.com Services LLC	ab1681df-aded-4b0c-9124-87196606183b	2024-11-02	Warnings	Exact identifier application number: M002
Good Sense Gas Relief Extra Strength	SIMETHICONE	L. Perrigo Company	6b2d8591-cc58-457e-92b6-c719eee85605	2024-11-02	Warnings	Exact identifier application number: M002
premier value infants gas relief	SIMETHICONE	Chain Drug Consortium	7b887e53-a70a-4f33-9472-e1175b24400a	2024-10-28	Warnings	Exact identifier application number: M002
Premier Value Extra Strength	SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	df2b1b62-5bd2-4d02-86c2-537b965a8d20	2024-10-28	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	4ce98db3-c7a6-4627-88c5-9de302a53188	4
314221	simethicone 125 MG Chewable Tablet	SCD	4ce98db3-c7a6-4627-88c5-9de302a53188	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0137-1	17856013701	100 POUCH in 1 BOX, UNIT-DOSE (17856-0137-1) / 1 TABLET, CHEWABLE in 1 POUCH	100 pouch	2022-09-29	0000-00-00	No	No	Current
17856-0137-2	17856013702	1 TABLET, CHEWABLE in 1 POUCH (17856-0137-2)		2022-09-29		No	No	Current