Simethicone 250mg

Product NDC: 73629-006
11-digit product format: 736290006
Labeler code: 73629
Product ID: 73629-006_2b3b212d-55b4-ca76-e063-6394a90a984e
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone 250mg
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: AMZ789 LLC
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-12-01
Substance: DIMETHICONE
Active strength: 250 mg/1
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Simethicone 250mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	250 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
412111	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
fcc2ef8b-9181-2c59-e053-6394a90adcc1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73629-006-12	Simethicone 250mg	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73629-006	SIMETHICONE 250MG CAPSULE, LIQUID FILLED [AMZ789 LLC]	2	Current NDC, 1 package rows	20250110_fcc2ef8b-9181-2c59-e053-6394a90adcc1.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

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
412111	simethicone 250 MG Oral Capsule	PSN	fcc2ef8b-9181-2c59-e053-6394a90adcc1	2
412111	simethicone 250 MG Oral Capsule	SCD	fcc2ef8b-9181-2c59-e053-6394a90adcc1	2
412111	dimethicone 250 MG Oral Capsule	SY	fcc2ef8b-9181-2c59-e053-6394a90adcc1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73629-006-12	73629000612	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (73629-006-12)	2022-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simethicone 250mg	AMZ789 LLC \| Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd	2025-01-08	HUMAN OTC DRUG LABEL	2