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 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
ndc (product): 0132-0211
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
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