Simethicone

Product NDC: 17714-040
Requested package NDC: 17714-040-60
11-digit product format: 177140040
Labeler code: 17714
Product ID: 17714-040_7d3cccab-252a-cd80-e053-2a91aa0acbcc
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Advance Pharmaceutical Inc.
Application: part332
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-11-01
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

Additional Listing Data#

Finished product: Yes
Brand name base: Simethicone
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
e11928e8-b9db-43c5-972b-33b325090dfc	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17714-040-60	Simethicone	60 in 1 BOTTLE	TABLET, CHEWABLE	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17714-040	SIMETHICONE TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]	4	Current NDC, Legacy NDC, 1 package rows	20181218_e11928e8-b9db-43c5-972b-33b325090dfc.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	Advance Pharmaceutical Inc.	e11928e8-b9db-43c5-972b-33b325090dfc	2018-12-17	Warnings	Exact identifier ndc (package): 17714-040-60 ndc (product): 17714-040 ndc11 (package): 17714004060

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	e11928e8-b9db-43c5-972b-33b325090dfc	4
314221	simethicone 125 MG Chewable Tablet	SCD	e11928e8-b9db-43c5-972b-33b325090dfc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17714-040-60	17714004060	60 TABLET, CHEWABLE in 1 BOTTLE (17714-040-60)	2012-11-01	0000-00-00	No	No	Current