CVS PHARMACY

Product NDC: 51316-111
11-digit product format: 513160111
Labeler code: 51316
Product ID: 51316-111_eaa66539-08b1-4562-933e-bdadde04ad23
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: CVS
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-08-06
Substance: DIMETHICONE, UNSPECIFIED
Active strength: 80 mg/1
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: CVS PHARMACY
Brand name suffix: Gas relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE, UNSPECIFIED	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
c2a3a978-c957-4453-88b3-53f4e80a2465	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-111-00	CVS PHARMACYGas relief	100 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-111	CVS PHARMACY GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CVS]	4	Current NDC, Legacy NDC, 1 package rows	20240817_c2a3a978-c957-4453-88b3-53f4e80a2465.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Gas	SIMETHICONE	Allegiant Health	7731bd63-667e-4fed-b446-92a4a83b66d6	2020-11-03	Warnings	Exact identifier application number: M002
Anti-Gas	SIMETHICONE	Marc Glassman, Inc.	e99f2041-2543-4331-9f54-9eea179f94d2	2020-10-06	Warnings	Exact identifier application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314216	simethicone 80 MG Chewable Tablet	PSN	c2a3a978-c957-4453-88b3-53f4e80a2465	5
314216	simethicone 80 MG Chewable Tablet	SCD	c2a3a978-c957-4453-88b3-53f4e80a2465	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-111-00	51316011100	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51316-111-00)	2021-08-06	0000-00-00	No	No	Current