Simethicone

Manufacturer: Contract Pharmacal Corp.
Effective date: 2024-02-09
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:08:28

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE 410

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prestige Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	3
252294	simethicone 180 MG Oral Capsule	SCD	3
252294	dimethicone 180 MG Oral Capsule	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10267-5328-8	Simethicone	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		3
10267-5328-8	Simethicone	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10267-5328	SIMETHICONE CAPSULE, LIQUID FILLED [CONTRACT PHARMACAL CORP.]	3	2 package rows	20240210_a369acc0-703c-6cd4-e053-2995a90a195a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Simethicone
DIMETHICONE 410
GLYCERIN
FD&C RED NO. 40
GELATIN
FD&C YELLOW NO. 6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10267-5328	10267-5328-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE 410	TYU5GP6XGE	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT

Source Document#

Source XML · Source PDF

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
10f75041-6870-13ce-e063-6394a90ac5d5			a369acc0-703c-6cd4-e053-2995a90a195a	2024-02-09		Exact identifier spl id: 10f75041-6870-13ce-e063-6394a90ac5d5 spl set id: a369acc0-703c-6cd4-e053-2995a90a195a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.