Simethicone

Product NDC
55629-010
11-digit product format
556290010
Labeler code
55629
Product ID
55629-010_4a22bbdb-7623-41f1-a392-2436d0f2cce1
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ONE2ZEE LIMITED LIABILITY COMPANY
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-19
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
125 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-010-012025-01-30C16284748780-1f386c649-a907-0266-e053-dadaa90a7c1aExtra Strength Gas Relief
55629-010-012023-03-25C16284748780-1f386c649-a907-0266-e053-dadaa90a7c1aExtra Strength Gas Relief
55629-010-012023-01-30C16284748780-1f386c649-a907-0266-e053-dadaa90a7c1aExtra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-010-01Simethicone48 in 1 CARTONCAPSULE, LIQUID FILLED483
55629-010-02Simethicone1500 in 1 POUCHCAPSULE, LIQUID FILLED15003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-010SIMETHICONE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]3Legacy NDC, 2 package rows20230326_a2d1fc2d-6bb1-459d-900a-7e4f329792b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNa2d1fc2d-6bb1-459d-900a-7e4f329792b13
198852simethicone 125 MG Oral CapsuleSCDa2d1fc2d-6bb1-459d-900a-7e4f329792b13
198852dimethicone 125 MG Oral CapsuleSYa2d1fc2d-6bb1-459d-900a-7e4f329792b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55629-010-015562900100148 POUCH in 1 CARTON (55629-010-01) > 1500 CAPSULE, LIQUID FILLED in 1 POUCH (55629-010-02) 48 pouch2021-01-190000-00-00NoNoCurrent
55629-010-02556290010021500 in 1 POUCHHistorical