Simethicone

Product NDC: 54738-518
11-digit product format: 547380518
Labeler code: 54738
Product ID: 54738-518_5cc86981-732a-038f-e053-2991aa0a19d4
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Richmond Pharmaceuticals, Inc.
Application: part332
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-03-01
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

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
f4be1c0d-01fc-4681-9068-905ed3184534	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
54738-518-01	Simethicone	100 in 1 BOTTLE	TABLET, CHEWABLE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54738-518-01	EA - Each	54738-518	a5c24841-d4d6-4807-bdce-d40c01f1e628	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54738-518	SIMETHICONE TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20171030_f4be1c0d-01fc-4681-9068-905ed3184534.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	Richmond Pharmaceuticals, Inc.	f4be1c0d-01fc-4681-9068-905ed3184534	2017-10-30	Warnings	Exact identifier ndc (product): 54738-518

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	da0cc98e-1692-405a-ab81-420d6f9df6de	3
314216	simethicone 80 MG Chewable Tablet	SCD	da0cc98e-1692-405a-ab81-420d6f9df6de	3
314216	simethicone 80 MG Chewable Tablet	PSN	f4be1c0d-01fc-4681-9068-905ed3184534	2
314216	simethicone 80 MG Chewable Tablet	SCD	f4be1c0d-01fc-4681-9068-905ed3184534	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54738-518-01	54738051801	100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)	2011-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GAS RELIEF SIMETHICONE	Aphena Pharma Solutions - Tennessee, LLC	2026-07-31	HUMAN OTC DRUG LABEL	4
GAS RELIEF SIMETHICONE	Richmond Pharmaceuticals, Inc. \| Advance Pharmaceutical Inc.	2017-10-30	HUMAN OTC DRUG LABEL	2