Leader Gas relief

Product NDC
70000-0434
11-digit product format
700000434
Labeler code
70000
Product ID
70000-0434_c598e7be-e58f-4812-8a05-f03d9303053b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-07
Substance
DIMETHICONE
Active strength
80 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Gas relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314216

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0434-1Leader Gas relief100 in 1 BOTTLETABLET, CHEWABLE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0434-1EA - Each70000-0434174f7308-4ae5-4154-b2ff-8645a2a0330912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0434LEADER GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 1 package rows20241219_0163d372-222e-4a8d-a5cb-5a7af9a7068c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSN0163d372-222e-4a8d-a5cb-5a7af9a7068c4
314216simethicone 80 MG Chewable TabletSCD0163d372-222e-4a8d-a5cb-5a7af9a7068c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0434-170000043401100 TABLET, CHEWABLE in 1 BOTTLE (70000-0434-1) 2019-06-070000-00-00NoNoCurrent