FDA.reportPublic FDA data

PHAZYME

Product NDC
0132-0215
11-digit product format
001320215
Labeler code
0132
Product ID
0132-0215_f7bd29f0-09fe-4cb3-af7d-bc35c5737bba
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
C.B. Fleet Company, Inc.
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-04-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0215-372021-01-29C16284748780-1ba0f9c33-22b8-a910-e053-dadaa90a0b85Phazyme Anti-Gas

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0215-37PHAZYME1 in 1 BOXCAPSULE, GELATIN COATED12
0132-0215-37PHAZYME36 in 1 BLISTER PACKCAPSULE, GELATIN COATED362

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0215-37EA - Each0132-021506914737-7c40-4d94-8786-81ff64150f5c12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0215PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]2Legacy NDC, 2 package rows20170902_ef3cb514-3c84-45eb-bf21-afeea5ecb9be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537320PhaZyme 250 MG Oral CapsulePSNef3cb514-3c84-45eb-bf21-afeea5ecb9be2
412111simethicone 250 MG Oral CapsulePSNef3cb514-3c84-45eb-bf21-afeea5ecb9be2
1537320simethicone 250 MG Oral Capsule [Phazyme]SBDef3cb514-3c84-45eb-bf21-afeea5ecb9be2
412111simethicone 250 MG Oral CapsuleSCDef3cb514-3c84-45eb-bf21-afeea5ecb9be2
412111dimethicone 250 MG Oral CapsuleSYef3cb514-3c84-45eb-bf21-afeea5ecb9be2
1537320Phazyme 250 MG Oral CapsuleSYef3cb514-3c84-45eb-bf21-afeea5ecb9be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0132-0215-37001320215371 in 1 BOXHistorical