SIMETHICONE

Product NDC: 68210-1902
11-digit product format: 682101902
Labeler code: 68210
Product ID: 68210-1902_ff5ca266-7b84-4f5c-8618-3b08556b964e
Type: HUMAN OTC DRUG
Nonproprietary name: DIMETHICONE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS,LLC
Application: part310.545
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-10-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 180 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-1902		I	Inactivated by FDA	2026-10-15
excluded package	package	68210-1902	68210-1902-1	I	Inactivated by FDA	2026-10-15
excluded package	package	68210-1902	68210-1902-2	I	Inactivated by FDA	2026-10-15
excluded package	package	68210-1902	68210-1902-3	I	Inactivated by FDA	2026-10-15
excluded package	package	68210-1902	68210-1902-4	I	Inactivated by FDA	2026-10-15
excluded package	package	68210-1902	68210-1902-5	I	Inactivated by FDA	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 132 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1902-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1902-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1902-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1902-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1902-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1902-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1902-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1902-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1902-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1902-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1902-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1902-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1902-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1902-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1902-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1902-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1902-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1902-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1902-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1902-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1902-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1902-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1902-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1902-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1902-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1902-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1902-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1902-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1902-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1902-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1902-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1902-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1902-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1902-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1902-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1902-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1902-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1902-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1902-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1902-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1902-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1902-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1902-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1902-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1902-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1902-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1902-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1902-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1902-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1902-4	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68210-1902-1	SIMETHICONE CAPSULES USP 180 MG
68210-1902-2	SIMETHICONE CAPSULES USP 180 MG
68210-1902-3	SIMETHICONE CAPSULES USP 180 MG
68210-1902-4	SIMETHICONE CAPSULES USP 180 MG
68210-1902-5	SIMETHICONE CAPSULES USP 180 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-1902-1	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	1
68210-1902-1	SIMETHICONE	10 in 1 BAG	CAPSULE, LIQUID FILLED	10	1
68210-1902-2	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	1
68210-1902-2	SIMETHICONE	30 in 1 BAG	CAPSULE, LIQUID FILLED	30	1
68210-1902-3	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	1
68210-1902-3	SIMETHICONE	1000 in 1 BAG	CAPSULE, LIQUID FILLED	1000	1
68210-1902-4	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	1
68210-1902-4	SIMETHICONE	16000 in 1 BAG	CAPSULE, LIQUID FILLED	16000	1
68210-1902-5	SIMETHICONE	20000 in 1 BAG	CAPSULE, LIQUID FILLED	20000	1
68210-1902-5	SIMETHICONE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-1902	SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 10 package rows	20091203_2700e23e-2dad-4b7d-a9e1-db21dfbf4f26.zip

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
252294	simethicone 180 MG Oral Capsule	PSN	2700e23e-2dad-4b7d-a9e1-db21dfbf4f26	1
252294	simethicone 180 MG Oral Capsule	SCD	2700e23e-2dad-4b7d-a9e1-db21dfbf4f26	1
252294	dimethicone 180 MG Oral Capsule	SY	2700e23e-2dad-4b7d-a9e1-db21dfbf4f26	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68210-1902-1	68210190201	1 in 1 BOX	Historical
68210-1902-2	68210190202	1 in 1 BOX	Historical
68210-1902-3	68210190203	1 in 1 BOX	Historical
68210-1902-4	68210190204	1 in 1 BOX	Historical
68210-1902-5	68210190205	20000 in 1 BAG	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMETHICONE CAPSULES USP 180 MG	SPIRIT PHARMACEUTICALS,LLC \| SOFTGEL HEALTHCARE PVT LTD	2009-12-02	HUMAN OTC DRUG LABEL	1