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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui252294, 352091

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

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 bottle2012-02-01NoNoHistorical