Simethicone

Product NDC
55629-017
11-digit product format
556290017
Labeler code
55629
Product ID
55629-017_4911eb95-b86f-4790-9680-f63a3204a987
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ONE2ZEE LIMITED LIABILITY COMPANY
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-02
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-017-01Simethicone48 in 1 CARTONCAPSULE, LIQUID FILLED482
55629-017-02Simethicone1500 in 1 POUCHCAPSULE, LIQUID FILLED15002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-017SIMETHICONE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]2Legacy NDC, 2 package rows20230326_3292fe8e-a41a-4890-baf2-575752704a48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN3292fe8e-a41a-4890-baf2-575752704a482
412111simethicone 250 MG Oral CapsuleSCD3292fe8e-a41a-4890-baf2-575752704a482
412111dimethicone 250 MG Oral CapsuleSY3292fe8e-a41a-4890-baf2-575752704a482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55629-017-015562900170148 POUCH in 1 CARTON (55629-017-01) > 1500 CAPSULE, LIQUID FILLED in 1 POUCH (55629-017-02) 48 pouch2021-03-020000-00-00NoNoCurrent
55629-017-02556290017021500 in 1 POUCHHistorical