CVS PHARMACY

Product NDC: 51316-110
Requested package NDC: 51316-110-18
11-digit product format: 513160110
Labeler code: 51316
Product ID: 51316-110_ae481994-9f88-49b2-b56a-7bfb66f3d7a5
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: CVS
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-08-05
Substance: DIMETHICONE, UNSPECIFIED
Active strength: 125 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: Extra Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE, UNSPECIFIED	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
98db6216-897c-4cf6-a4b7-b913ae3a2496	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51316-110-00	CVS PHARMACYExtra Strength	100 in 1 CARTON	TABLET, CHEWABLE	100	6
51316-110-18	CVS PHARMACYExtra Strength	9 in 1 BLISTER PACK	TABLET, CHEWABLE	9	6
51316-110-18	CVS PHARMACYExtra Strength	2 in 1 CARTON	TABLET, CHEWABLE	2	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-110	CVS PHARMACY EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [CVS]	5	Current NDC, Legacy NDC, 3 package rows	20240326_98db6216-897c-4cf6-a4b7-b913ae3a2496.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 9 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GNP Regular Strength Gas Relief	DIMETHICONE	Amerisource Bergen	7b63b265-e4f2-4103-935c-22d2d89cc5e8	2024-12-26	Warnings	Exact identifier application number: M002
Infants Gas relief	SIMETHICONE	Topco Associates, LLC	fd6a2537-8db2-492d-b045-6404df2fb9c3	2024-12-26	Warnings	Exact identifier application number: M002
Equaline Stomach Relief	BISMUTH SUBSALICYLATE	UNITED NATURAL FOODS, INC. DBA UNFI	5dae8bbe-219b-4aa1-bf7f-6471fa2856d9	2024-12-20	Warnings	Exact identifier application number: M002
GNP Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Amerisource Bergen	ead13b6b-de37-49f9-b18e-68096651d47e	2024-12-20	Warnings	Exact identifier application number: M002
Infants Gas relief	SIMETHICONE	UNITED NATURAL FOODS, INC. DBA UNFI	a9902ba0-f239-4e66-8d66-7cef39a5fdc3	2024-12-20	Warnings	Exact identifier application number: M002
GNP Pink Bismuth	BISMUTH SUBSALICYLATE	Amerisource Bergen	a6ed50d5-574f-4d6b-be48-e14659338993	2024-12-20	Warnings	Exact identifier application number: M002
WinCo Foods Gas Relief Extra Strength Softgels	SIMETHICONE	WinCo Foods, LLC	a1a19ef7-4a14-4fcb-8917-631d867be0bb	2024-12-18	Warnings	Exact identifier application number: M002
Discount Drugmart Gas Relief Extra Strength Softgels	SIMETHICONE	Discount Drug Mart, Inc	63f3e5f0-10da-4681-a4f1-8ca1eb7e390f	2024-12-18	Warnings	Exact identifier application number: M002
Quality Choice Gas Relief Extra Strength Softgels	SIMETHICONE	Chain Drug Marketing Association	06dfb541-fd1f-4cee-a4a6-44252f1f65a0	2024-12-18	Warnings	Exact identifier application number: M002
Leader Gas relief	SIMETHICONE	CARDINAL HEALTH 110, LLC. DBA LEADER	0163d372-222e-4a8d-a5cb-5a7af9a7068c	2024-12-17	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief Softgel-60ct	SIMETHICONE	HEB	f65e362a-2f90-428a-b885-eefdad8cae1e	2024-12-16	Warnings	Exact identifier application number: M002
Maximum Strength Gas Relief	SIMETHICONE	Chain Drug Marketing Association, Inc.	e8b2c528-121d-519a-e053-2a95a90a4119	2024-12-16	Warnings	Exact identifier application number: M002
Gas Relief Ultra Strength	DIMETHICONE	TOPCO ASSOCIATES LLC	b9a4c876-722b-4d6c-807f-005ccf5df320	2024-12-14	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	DIMETHICONE	TOPCO ASSOCIATES LLC	bb1c54d4-3a36-4b77-8659-2e92845d2f0e	2024-12-14	Warnings	Exact identifier application number: M002
Foster and Thrive Extra Strength Gas Relief Cherry	SIMETHICONE	Strategic Sourcing Services LLC	e47374c8-05c1-4874-871b-e83d9b305bd3	2024-12-13	Warnings	Exact identifier application number: M002
Gas-X Extra Strength	SIMETHICONE	Haleon US Holdings LLC	7ce312ca-542b-4bc0-97b5-f65279e1e84c	2024-12-13	Warnings	Exact identifier application number: M002
Antacid Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	c8173d42-f900-4527-aa56-472d1177a9bc	2024-12-11	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36	2024-11-25	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	f7c40b12-11e4-4b85-afb2-0ea33e4f218c	2024-11-25	Warnings	Exact identifier application number: M002
Simethicone	SIMETHICONE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	346df37d-b0fc-4fa5-8c19-492fed58c239	2024-11-25	Warnings	Exact identifier application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	98db6216-897c-4cf6-a4b7-b913ae3a2496	6
314221	simethicone 125 MG Chewable Tablet	SCD	98db6216-897c-4cf6-a4b7-b913ae3a2496	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-110-18	51316011018	2 BLISTER PACK in 1 CARTON (51316-110-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK	2 blister pack	2021-08-05	0000-00-00	No	No	Current