FDA.reportPublic FDA data

Phazyme Ultimate

Product NDC
0132-0222
11-digit product format
001320222
Labeler code
0132
Product ID
0132-0222_7a0be931-8446-4b99-b7a2-d104acfc9af0
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
C.B. Fleet Company, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-13
Substance
DIMETHICONE
Active strength
500 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0132-02220132-0222-10DDiscontinued by firm2026-10-15

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 Ultimate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2477951Internal RxNorm lookup
2478331Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0222-10Phazyme Ultimate1 in 1 BOXCAPSULE, LIQUID FILLED13
0132-0222-10Phazyme Ultimate10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
0132-0222-20Phazyme Ultimate10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
0132-0222-20Phazyme Ultimate2 in 1 BOXCAPSULE, LIQUID FILLED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0222PHAZYME ULTIMATE (SIMETHICONE) CAPSULE, LIQUID FILLED [C.B. FLEET COMPANY, INC.]1Current NDC, 4 package rows20240814_c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662.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 6 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEMeijer Distribution, Inc.7723821e-b2fc-4c9c-a389-05184aaea19f2025-11-15WarningsExact identifier
application number: M002
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
application number: M002
up and up extra strength gas relief chewables Extra StrengthSIMETHICONETarget Corporation0a015c48-680c-4de1-91e7-1c1145239d8e2025-11-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
application number: M002
PUBLIX Extra StrengthSIMETHICONEPUBLIX SUPER MARKETS, INC089d77c9-7aa0-4eee-8363-c47a2d5928cf2025-10-28WarningsExact identifier
application number: M002
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
application number: M002
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
application number: M002
Infants Gas Relief DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
application number: M002
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
application number: M002
Quality Choice Infants Gas Relief Dye FreeSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)841b85ef-2ac8-4dac-8659-cffb7e1b1e052025-08-23WarningsExact identifier
application number: M002
CVS Health Gas Relief SOFTGELSIMETHICONECVS Pharmacy, Inc2911cac8-45ec-1294-e063-6294a90a4a742025-08-22WarningsExact identifier
application number: M002
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
application number: M002
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2478331Phazyme 500 MG Oral CapsulePSNc8e9f6ac-2db2-4d21-a4b1-5ca6c31056623
2477951simethicone 500 MG Oral CapsulePSNc8e9f6ac-2db2-4d21-a4b1-5ca6c31056623
2478331simethicone 500 MG Oral Capsule [Phazyme]SBDc8e9f6ac-2db2-4d21-a4b1-5ca6c31056623
2477951simethicone 500 MG Oral CapsuleSCDc8e9f6ac-2db2-4d21-a4b1-5ca6c31056623
2478331Phazyme 500 MG Oral CapsuleSYc8e9f6ac-2db2-4d21-a4b1-5ca6c31056623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0132-0222-10001320222101 in 1 BOXHistorical
0132-0222-20001320222202 BLISTER PACK in 1 BOX (0132-0222-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-03-13NoNoCurrent