PHAZYME

Product NDC: 0132-0208
11-digit product format: 001320208
Labeler code: 0132
Product ID: 0132-0208_4e5bbba1-8943-40b8-aaa7-1ab9bdcbfd10
Type: HUMAN OTC DRUG
Nonproprietary name: Simethicone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: C.B. Fleet Company, Inc.
Application: M002
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-01
Substance: DIMETHICONE
Active strength: 180 mg/1
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0132-0208	0132-0208-48	D	Discontinued by firm		2026-10-12

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 1 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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: PHAZYME
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	180 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
252294	Internal RxNorm lookup
352091	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
3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0132-0208-12	PHAZYME	1 in 1 BOX	CAPSULE, GELATIN COATED	1	15
0132-0208-12	PHAZYME	12 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	12	15
0132-0208-48	PHAZYME	48 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	48	15
0132-0208-48	PHAZYME	1 in 1 BOX	CAPSULE, GELATIN COATED	1	15
0132-0208-84	PHAZYME	1 in 1 BOX	CAPSULE, GELATIN COATED	1	15
0132-0208-84	PHAZYME	48 in 1 BOTTLE	CAPSULE, GELATIN COATED	48	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0132-0208-60	EA - Each	0132-0208	cd9abbec-6577-454a-ab66-0d2b78ce7512	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	7
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0132-0208	PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]	13	Current NDC, Legacy NDC, 6 package rows	20250101_3bb5cc1f-554b-4a4d-b9e9-665e34924b4b.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 3 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gas Relief	SIMETHICONE	CVS PHARMACY, INC	4ff77b4c-9616-4341-9bf8-eca301345a5f	2026-05-21	Warnings	Exact identifier application number: M002
Phazyme Ultimate	SIMETHICONE	C.B. Fleet Company, Inc.	c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662	2026-05-20	Warnings	Exact identifier application number: M002
gas relief	SIMETHICONE	United Natural Foods, Inc. dba UNFI	2a82a06d-7511-4fc0-b182-9c1774b2af48	2026-05-15	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	CVS PHARMACY, INC	b114b07e-6822-465a-9e74-2a741ccb19f7	2026-05-14	Warnings	Exact identifier application number: M002
Firstcare Gas Relief Simethicone 250 mg Anti-gas	SIMETHICONE 250 MG	USpharma Ltd	9625a697-fadc-483b-b83a-fa2cc76002ba	2026-05-12	Warnings	Exact identifier application number: M002
Firstcare Gas Relief Simethicone 125 mg Anti-gas	SIMETHICONE 125 MG	USpharma Ltd	e92c9661-01f2-42be-af54-42e60efcae35	2026-05-12	Warnings	Exact identifier application number: M002
Recuren Plus Antifungal Cream	MICONAZOLE NITRATE 2%	REGENEREN PLUS LTD	3c28a93a-dd42-65b8-e063-6294a90ae6ab	2026-05-07	Warnings	Exact identifier application number: M002
mylanta gas	SIMETHICONE	Infirst Healthcare	ce925db4-fe1a-4069-96be-ce86cdd4e79a	2026-05-01	Warnings	Exact identifier application number: M002
PHAZYME	SIMETHICONE	C.B. Fleet Company, Inc.	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	2026-04-29	Warnings	Exact identifier application number: M002 ndc (product): 0132-0208
Childrens Emetrol Multi Symptom Upset Stomach Relief	CHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEF	WellSpring Pharmaceutical Corporation	fe9ccc29-3cca-4666-9bb5-abb41816b3f5	2026-04-23	Warnings	Exact identifier application number: M002
Little Remedies Gas Relief Drops	SIMTHICONE	Medtech Products Inc.	874d3f1d-1e4a-49ab-8285-4d6bf2601d5e	2026-04-23	Warnings	Exact identifier application number: M002
good sense gas relief	SIMETHICONE	Preferred Pharmaceuticals Inc.	06836246-9058-42af-a8a3-5aec81f4b9cc	2026-04-20	Warnings	Exact identifier application number: M002
Gas Relief	SIMETHICONE	Walgreens	52cceb6b-f2c8-49bf-b5ce-5d1c999a9b60	2026-04-17	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	Best Choice (Valu Merchandisers Company)	ce18af91-1c60-44b1-aed2-4f54d394e27e	2026-04-13	Warnings	Exact identifier application number: M002
Gas Relief Extra Strength	SIMETHICONE	H E B	c153585f-0f44-40ad-8246-5d9edae8325e	2026-04-02	Warnings	Exact identifier application number: M002
ultra strength gas relief	SIMETHICONE	BIONPHARMA INC.	4e6ac834-9ce3-1b54-e063-6294a90a9dff	2026-04-01	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief Cherry	SIMETHICONE	Good Sense (Geiss, Destin & Dunn, Inc.)	91f72cf2-297d-48db-8f05-f8a7050d92e8	2026-03-31	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Hyvee Inc	44ea37b1-8cd2-936d-e063-6394a90a2be7	2026-03-27	Warnings	Exact identifier application number: M002
Extra Strength Gas Relief	SIMETHICONE	Grocery Outlet, Inc.	44672e28-3305-a8cc-e063-6394a90a5fef	2026-03-23	Warnings	Exact identifier application number: M002
gas relief	SIMETHICONE	BIONPHARMA INC.	4d7a9507-6f3c-6d15-e063-6294a90a0160	2026-03-20	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
352091	PhaZyme Ultra Strength 180 MG Oral Capsule	PSN	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15
252294	simethicone 180 MG Oral Capsule	PSN	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15
352091	simethicone 180 MG Oral Capsule [Phazyme]	SBD	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15
252294	simethicone 180 MG Oral Capsule	SCD	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15
252294	dimethicone 180 MG Oral Capsule	SY	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15
352091	Phazyme 180 MG Oral Capsule	SY	3bb5cc1f-554b-4a4d-b9e9-665e34924b4b	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0132-0208-12	00132020812	1 BLISTER PACK in 1 BOX (0132-0208-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK	1 blister pack	2012-02-01	0000-00-00	No	No	Current
0132-0208-48	00132020848	1 BLISTER PACK in 1 BOX (0132-0208-48) > 48 CAPSULE, GELATIN COATED in 1 BLISTER PACK	1 blister pack	2012-02-01	0000-00-00	No	No	Current
0132-0208-84	00132020884	1 BOTTLE in 1 BOX (0132-0208-84) / 48 CAPSULE, GELATIN COATED in 1 BOTTLE	1 bottle	2012-02-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phazyme Ultra Strength 180 mg 0132-0208	C.B. Fleet Company, Inc.	2026-04-29	HUMAN OTC DRUG LABEL	15