FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0132-02080132-0208-48DDiscontinued by firm2026-10-12

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…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
IngredientStrength
DIMETHICONE180 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
252294Internal RxNorm lookup
352091Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bb5cc1f-554b-4a4d-b9e9-665e34924b4bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0208-12PHAZYME1 in 1 BOXCAPSULE, GELATIN COATED115
0132-0208-12PHAZYME12 in 1 BLISTER PACKCAPSULE, GELATIN COATED1215
0132-0208-48PHAZYME48 in 1 BLISTER PACKCAPSULE, GELATIN COATED4815
0132-0208-48PHAZYME1 in 1 BOXCAPSULE, GELATIN COATED115
0132-0208-84PHAZYME1 in 1 BOXCAPSULE, GELATIN COATED115
0132-0208-84PHAZYME48 in 1 BOTTLECAPSULE, GELATIN COATED4815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0208-60EA - Each0132-0208cd9abbec-6577-454a-ab66-0d2b78ce751212015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]7
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0208PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]13Current NDC, Legacy NDC, 6 package rows20250101_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 9 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
application number: M002
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI5dae8bbe-219b-4aa1-bf7f-6471fa2856d92024-12-20WarningsExact identifier
application number: M002
GNP Stomach ReliefBISMUTH SUBSALICYLATE 525 MGAmerisource Bergenead13b6b-de37-49f9-b18e-68096651d47e2024-12-20WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFIa9902ba0-f239-4e66-8d66-7cef39a5fdc32024-12-20WarningsExact identifier
application number: M002
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergena6ed50d5-574f-4d6b-be48-e146593389932024-12-20WarningsExact identifier
application number: M002
WinCo Foods Gas Relief Extra Strength SoftgelsSIMETHICONEWinCo Foods, LLCa1a19ef7-4a14-4fcb-8917-631d867be0bb2024-12-18WarningsExact identifier
application number: M002
Discount Drugmart Gas Relief Extra Strength SoftgelsSIMETHICONEDiscount Drug Mart, Inc63f3e5f0-10da-4681-a4f1-8ca1eb7e390f2024-12-18WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association06dfb541-fd1f-4cee-a4a6-44252f1f65a02024-12-18WarningsExact identifier
application number: M002
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
application number: M002
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthDIMETHICONETOPCO ASSOCIATES LLCb9a4c876-722b-4d6c-807f-005ccf5df3202024-12-14WarningsExact identifier
application number: M002
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
application number: M002
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
application number: M002
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd0c9c5fec-ddd4-41a5-8ff9-6b55c376dd362024-11-25WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.f7c40b12-11e4-4b85-afb2-0ea33e4f218c2024-11-25WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352091PhaZyme Ultra Strength 180 MG Oral CapsulePSN3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15
252294simethicone 180 MG Oral CapsulePSN3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15
352091simethicone 180 MG Oral Capsule [Phazyme]SBD3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15
252294simethicone 180 MG Oral CapsuleSCD3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15
252294dimethicone 180 MG Oral CapsuleSY3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15
352091Phazyme 180 MG Oral CapsuleSY3bb5cc1f-554b-4a4d-b9e9-665e34924b4b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0208-12001320208121 BLISTER PACK in 1 BOX (0132-0208-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK1 blister pack2012-02-010000-00-00NoNoCurrent
0132-0208-48001320208481 BLISTER PACK in 1 BOX (0132-0208-48) > 48 CAPSULE, GELATIN COATED in 1 BLISTER PACK1 blister pack2012-02-010000-00-00NoNoCurrent
0132-0208-84001320208841 BOTTLE in 1 BOX (0132-0208-84) / 48 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2012-02-01NoNoCurrent