Antiflatulent

Product NDC: 71610-650
11-digit product format: 716100650
Labeler code: 71610
Product ID: 71610-650_2b5b34d8-29c2-fc54-e063-6394a90aaa7a
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-10-04
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	71610-650		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71610-650	71610-650-04	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`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: Antiflatulent
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
dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-650-04	Antiflatulent	4 in 1 BOTTLE	TABLET, CHEWABLE	4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-650-04	EA - Each	71610-650	39e8a1c8-7af7-48a9-ad0a-a5a24875b174	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-650	ANTIFLATULENT (SIMETHICONE) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250112_dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea.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
314216	simethicone 80 MG Chewable Tablet	PSN	dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea	4
314216	simethicone 80 MG Chewable Tablet	SCD	dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-650-04	71610065004	4 TABLET, CHEWABLE in 1 BOTTLE (71610-650-04)	2022-05-19	0000-00-00	No	No	Current