SIMETHICONE

Product NDC: 68071-2746
11-digit product format: 680712746
Labeler code: 68071
Product ID: 68071-2746_2eeb54a1-cc84-0293-e063-6294a90a8f00
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M008
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-01
Substance: DIMETHICONE
Active strength: 80 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 · 6 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
2025-02-02 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	68071-2746-3	`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	68071-2746-3	`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	68071-2746-3	`0efc9e666f02…`	`f202fb6c5f17…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	80 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
314216	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
e07f6acc-1b75-d8eb-e053-2a95a90a7d9b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2746-3	2025-02-25	C162847	48780-1	2cef2736-97c3-d83d-e063-dadaa90ab31f	gc 791
68071-2746-3	2025-01-30	C162847	48780-1	2cef2736-97c3-d83d-e063-dadaa90ab31f	gc 791

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2746-3	SIMETHICONE	30 in 1 BOTTLE	TABLET, CHEWABLE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2746	SIMETHICONE TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 1 package rows	20250227_e07f6acc-1b75-d8eb-e053-2a95a90a7d9b.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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	CARDINAL HEALTH 110, LLC. DBA LEADER	7d6047a9-5557-487a-ae06-f904dac626c9	2025-10-14	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Atlantic Biologicals Corp	401f8393-680c-e1a8-e063-6394a90a81ab	2025-10-01	Warnings	Exact identifier application number: M008
First Aid Direct Peptum Tabs	BISMUTH SUBSALICYLATE	Cintas Corp	dd14cd57-3f7c-4634-9da9-6f83dc5bae12	2025-09-29	Warnings	Exact identifier application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgel	BISMUTH SUBSALICYLATE	Strive Pharmaceuticals Inc.	0f271054-fa96-4475-8279-65f4565aba36	2025-09-22	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate Suspension Regular Strength	BISMUTH SUBSALICYLATE	FSA Store Inc. (Caring Mill)	fbabc313-600a-4722-9948-1a3e21414059	2025-09-18	Warnings	Exact identifier application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEF	BISMUTH SUBSALICYLATE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	67c610b1-fe94-4ad3-ad1a-8bd93a4da9d9	2025-09-11	Warnings	Exact identifier application number: M008
Medique Diotame	BISMUTH SUBSALICYLATE	Unifirst First Aid Corporation	0667ec26-c2cd-153c-e054-00144ff88e88	2025-09-08	Warnings	Exact identifier application number: M008
McKesson Bismuth	BISMUTH SUBSALICYLATE	McKesson Medical-Surgical	d1f3dfa4-e021-6384-e053-2995a90a7b42	2025-09-08	Warnings	Exact identifier application number: M008
Medi-First Pep-T-Med	BISMUTH SUBSALICYLATE	Unifirst First Aid Corporation	88f4d5d4-92ed-40ab-97a9-181da72f869b	2025-09-08	Warnings	Exact identifier application number: M008
Thompson Chewable Bismuth Tabs	BISMUTH SUBSALICYLATE	Thompson Safety LLC	c94b9bc2-b764-a9a7-e053-2a95a90aed81	2025-09-08	Warnings	Exact identifier application number: M008
Goodsense Regular strength Stomach Relief 122	BISMUTH SUBSALICYLATE	Preferred Pharmaceuticals Inc.	f0588ab8-d1fc-419a-8d68-bee42332d50f	2025-08-01	Warnings	Exact identifier application number: M008
Ultra Strength Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Retail Business Services, LLC.	338ca589-91ff-30ed-e063-6294a90a243a	2025-07-21	Warnings	Exact identifier application number: M008
Regular Strength Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Retail Business Services, LLC.	338d61af-35a8-fba7-e063-6294a90a38e8	2025-07-21	Warnings	Exact identifier application number: M008
Senna	SENNOSIDES	Major Pharmaceuticals	cfb6bf89-c77e-4372-9bc9-44d6a659c955	2025-07-18	Warnings	Exact identifier application number: M008
Major Bismuth Subsalicylate	BISMUTH SUBSALICYLATE	Major Pharmaceuticals	2a7c9cc1-206e-4018-b89d-7b634df43df6	2025-07-11	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55440401-f82f-45a3-ba7e-6ccdfdacead3	2025-07-10	Warnings	Exact identifier application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mg	BISMUTH SUBSALICYLATE 262 MG	Pioneer Life Sciences, LLC	07e2cc82-ab0e-46c5-863b-67658b612678	2025-06-27	Warnings	Exact identifier application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mg	BISMUTH SUBSALICYLATE 262 MG	NUVICARE LLC	6697e464-00ac-41de-a7ea-d7bb24ed5e2a	2025-06-25	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	P & L Development, LLC	8383945f-b3a7-4242-bfaa-acf24b66406d	2025-05-30	Warnings	Exact identifier application number: M008
5-Symptom Digestive Relief	BISMUTH SUBSALICYLATE	TARGET CORPORATION	28fba615-48ca-8d96-e063-6394a90a2797	2025-04-12	Warnings	Exact identifier application number: M008

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
314216	simethicone 80 MG Chewable Tablet	PSN	e07f6acc-1b75-d8eb-e053-2a95a90a7d9b	2
314216	simethicone 80 MG Chewable Tablet	SCD	e07f6acc-1b75-d8eb-e053-2a95a90a7d9b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2746-3	68071274603	30 TABLET, CHEWABLE in 1 BOTTLE (68071-2746-3)	2022-06-02	0000-00-00	No	No	Current