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 8 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Gas Relief	SIMETHICONE	Harris Teeter, LLC	2c3a05de-6690-f49a-e063-6394a90a9085	2025-02-05	Warnings	Exact identifier application number: M002
Infants Gas relief	SIMETHICONE	Harris Teeter, LLC	2c39de90-4896-8a85-e063-6394a90af677	2025-02-05	Warnings	Exact identifier application number: M002
Curist Gas Relief Maximum Strength	SIMETHICONE	Little Pharma, Inc.	dc15a8e6-8924-f5c2-e053-2a95a90ab2c0	2025-02-04	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief Cherry	SIMETHICONE	Harris Teeter, LLC	2bd9ebda-520c-691a-e063-6294a90af7d3	2025-02-04	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	TARGET CORPORATION	f6ff3b61-8a47-14ec-e053-6294a90a2df8	2025-01-31	Warnings	Exact identifier application number: M002
Gas relief Anti-gas	SIMETHICONE	CVS	2bc548d2-7176-333b-e063-6394a90aae01	2025-01-29	Warnings	Exact identifier application number: M002
Ultrastrength Gas Relief	SIMETHICONE SOFT GELATIN CAPSULES	CVS PHARMACY, INC	24ceba32-eb30-902f-e063-6394a90a9fd5	2025-01-29	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief Cherry Creme	SIMETHICONE	CVS	2bc522c8-9df0-05b4-e063-6394a90af60c	2025-01-27	Warnings	Exact identifier application number: M002
HEB Gas Relief Extra Strength Peppermint	SIMETHICONE	H E B	52f6db66-ce4c-40dc-b483-6ba83977cd8b	2025-01-20	Warnings	Exact identifier application number: M002
Simethicone 125 mg	SIMETHICONE	Reliable 1 Laboratires LLC	330aed4b-7109-09b8-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M002
Simethicone 80 mg	SIMETHICONE	Reliable 1 Laboratories LLC	32fb242b-7051-072c-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M002
SIMETHICONE	SIMETHICONE	Aphena Pharma Solutions - Tennessee, LLC	5df94be7-0bc9-4be1-9982-8193e3a3c8ef	2025-01-10	Warnings	Exact identifier application number: M002
Antiflatulent	SIMETHICONE	Aphena Pharma Solutions - Tennessee, LLC	dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea	2025-01-10	Warnings	Exact identifier application number: M002
Anti-Gas Strip	SIMETHICONE	Calmour	c1576ee9-69ff-41ff-b2d0-7703c8fa8edd	2025-01-09	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	AMZ789 LLC	bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2	2025-01-08	Warnings	Exact identifier application number: M002
Simethicone 250mg	SIMETHICONE 250MG	AMZ789 LLC	fcc2ef8b-9181-2c59-e053-6394a90adcc1	2025-01-08	Warnings	Exact identifier application number: M002
extra strength Gas Relief cherry creme	SIMETHICONE	Amerisource Bergen	1e8e8d85-10e2-1273-e063-6394a90a1558	2025-01-08	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Advanced Rx LLC	5dcd50ae-370d-4e49-b981-db42b86c2ecb	2025-01-01	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief Softgel	SIMETHICONE	CVS PHARMACY, INC	de059bd9-40de-432d-9370-5d1e53bd89ac	2024-12-30	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Topco Associates, LLC	c90d68a0-22e1-4a37-8487-16ecdc431ede	2024-12-26	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