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…`

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 1 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON EXTRA STRENGTH	SIMETHICONE	AMAZON.COM SERVICES LLC	705489ce-ac7c-44a8-8298-ead19824582e	2026-08-06	Warnings	Exact identifier application number: M002
Gencare-Gas Relief	SIMETHICONE 180 MG	PIONEER LIFE SCIENCES, LLC	b7f2d5db-c1b7-4c01-8ee6-017e4b9f1425	2026-08-04	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	SOFTGEL HEALTHCARE PRIVATE LIMITED	322e6cb3-0ddc-9300-e063-6294a90a972a	2026-07-31	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Aphena Pharma Solutions - Tennessee, LLC	da0cc98e-1692-405a-ab81-420d6f9df6de	2026-07-31	Warnings	Exact identifier application number: M002
INFANTS GAS RELIEF DROPS	SIMETHICONE	RELIABLE 1 LABORATORIES	b479bf22-3469-7916-e053-2995a90addc8	2026-07-30	Warnings	Exact identifier application number: M002
Best Choice	SIMETHICONE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	245504a6-d2fc-4e05-871b-bab03f34e154	2026-07-17	Warnings	Exact identifier application number: M002
Best Choice Extra Strength	SIMETHICONE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	a41b2895-abbe-4cf1-9c42-0b5e902d298b	2026-07-17	Warnings	Exact identifier application number: M002
FEVIA Gas Control	SIMETHICONE	VIVUNT PHARMA LLC	4bd53a70-3ba0-364c-e063-6394a90a7a64	2026-07-16	Warnings	Exact identifier application number: M002
FEVIA Gas Control	SIMETHICONE	VIVUNT PHARMA LLC	4b1d1bce-eeef-b790-e063-6294a90a166e	2026-07-16	Warnings	Exact identifier application number: M002
Maximum Strength Antacid Mint	SIMETHICONE	Guardian Drug Company	48ec3132-17cf-1de9-e063-6294a90aa407	2026-07-14	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	cce7f7db-99b8-4d7d-ac77-43da6323ebe1	2026-07-14	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Rite Aid Corporation	43e94ffc-a3ec-4a16-98db-b000a6dc4230	2026-07-10	Warnings	Exact identifier application number: M002
Tea Tree Oil Antifungal	TOLNAFTATE	Guangzhou ChuanMa International Trading Co.,Ltd.	55a48fc6-1963-66ea-e063-6294a90a3501	2026-07-02	Warnings	Exact identifier application number: M002
RIGHT REMEDIES Extra Strength Gas Relief	SIMETHICONE	Strive Pharmaceuticals Inc.	2d651784-a17b-12bc-e063-6294a90a8ab2	2026-06-30	Warnings	Exact identifier application number: M002
Gas Relief	GAS RELIEF	Chain Drug Marketing Association, Inc.	912f896b-ff49-40e6-b425-c314e0cbf48e	2026-06-30	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Strategic Sourcing Services LLC	0add7687-f9d7-4f70-b9a8-1454db8a7caf	2026-06-29	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	447ee411-f4b9-4dd1-a3e0-36ad79bccbf9	2026-06-25	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	33bee4db-d4aa-4c72-8eeb-46ff374a92a6	2026-06-10	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	P & L Development, LLC	f4526eba-e6d0-44de-99ea-4af7a6dba199	2026-06-10	Warnings	Exact identifier application number: M002
SIMETHICONE	SIMETHICONE	YYBA	50250112-933c-ffb1-e063-6394a90aaafb	2026-06-09	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