PHAZYME

Product NDC
0132-0211
11-digit product format
001320211
Labeler code
0132
Product ID
0132-0211_59b75f9e-58e1-46f2-b704-99b93f93a90e
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
2014-04-01
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
PHAZYME
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 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
412111Internal RxNorm lookup
1537320Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea04f5a5-cf56-4176-a234-5a73e01ff218Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0211-12PHAZYME12 in 1 BLISTER PACKCAPSULE, GELATIN COATED1210
0132-0211-12PHAZYME1 in 1 BOXCAPSULE, GELATIN COATED110
0132-0211-24PHAZYME2 in 1 BOXCAPSULE, GELATIN COATED210
0132-0211-24PHAZYME12 in 1 BLISTER PACKCAPSULE, GELATIN COATED1210
0132-0211-36PHAZYME12 in 1 BLISTER PACKCAPSULE, GELATIN COATED1210
0132-0211-36PHAZYME3 in 1 BOXCAPSULE, GELATIN COATED310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0211-12EA - Each0132-0211557ac571-5517-4e30-b1ba-106fb774c44612015-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0211PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]9Current NDC, Legacy NDC, 6 package rows20241215_ea04f5a5-cf56-4176-a234-5a73e01ff218.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 12 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas-X Ultra Strength AntiGas SoftgelsSIMETHICONEHaleon US Holdings LLCee9a8404-0653-433f-90e5-7ac69bdab8df2024-04-05WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONECVS Pharmacybac06147-87ae-4aaa-a66b-4aeae6096d8d2024-03-13WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEWALGREENS03bc9c99-2871-2604-e063-6394a90a2be52024-03-06WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
application number: M002
Anti-Gas Ultra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)f74d9882-cc99-41b6-b851-ce89d28f33df2024-02-15WarningsExact identifier
application number: M002
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
application number: M002
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
application number: M002
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief OriginalSIMETHICONEInfirst Healthcare395be942-d883-4bcb-8811-6fe1521d5a922024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
application number: M002
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
application number: M002
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
application number: M002
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
application number: M002
GAS RELIEFSIMETHICONESTRATEGIC SOURCING SERVICES LLCff1fd97c-af4f-dffb-e053-6294a90a20392023-10-26WarningsExact identifier
application number: M002
INFANT GAS RELIEFSIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION7d3c3cc6-b0a2-620d-e053-2a91aa0a159b2023-07-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537320PhaZyme 250 MG Oral CapsulePSNea04f5a5-cf56-4176-a234-5a73e01ff21810
412111simethicone 250 MG Oral CapsulePSNea04f5a5-cf56-4176-a234-5a73e01ff21810
1537320simethicone 250 MG Oral Capsule [Phazyme]SBDea04f5a5-cf56-4176-a234-5a73e01ff21810
412111simethicone 250 MG Oral CapsuleSCDea04f5a5-cf56-4176-a234-5a73e01ff21810
412111dimethicone 250 MG Oral CapsuleSYea04f5a5-cf56-4176-a234-5a73e01ff21810
1537320Phazyme 250 MG Oral CapsuleSYea04f5a5-cf56-4176-a234-5a73e01ff21810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0211-12001320211121 BLISTER PACK in 1 BOX (0132-0211-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK1 blister pack2014-04-010000-00-00NoNoCurrent
0132-0211-24001320211242 BLISTER PACK in 1 BOX (0132-0211-24) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK2 blister pack2014-04-010000-00-00NoNoCurrent
0132-0211-36001320211363 BLISTER PACK in 1 BOX (0132-0211-36) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK3 blister pack2014-04-010000-00-00NoNoCurrent