FDA.reportPublic FDA data

Cardinal Health Infants Gas Relief

Product NDC
70000-0051
11-digit product format
700000051
Labeler code
70000
Product ID
70000-0051_411c8ca0-57d6-df9e-e063-6394a90ae833
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
CARDINAL HEALTH
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-02
Substance
DIMETHICONE, UNSPECIFIED
Active strength
20 mg/.3mL
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
Cardinal Health Infants Gas Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0051-1Cardinal Health Infants Gas Relief1 in 1 CARTONSUSPENSION/ DROPS17
70000-0051-1Cardinal Health Infants Gas Relief30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0051-1ML - Milliliter70000-0051d7d104ac-143a-4c03-8251-65384603e44b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0051CARDINAL HEALTH INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [CARDINAL HEALTH]6Current NDC, Legacy NDC, 2 package rows20241122_e0dec270-dabb-4289-b5e0-bf37f9ddcbcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSNe0dec270-dabb-4289-b5e0-bf37f9ddcbcd7
198857simethicone 66.7 MG/ML Oral SuspensionSCDe0dec270-dabb-4289-b5e0-bf37f9ddcbcd7
198857simethicone 20 MG per 0.3 ML Oral SuspensionSYe0dec270-dabb-4289-b5e0-bf37f9ddcbcd7
198857simethicone 40 MG per 0.6 ML Oral SuspensionSYe0dec270-dabb-4289-b5e0-bf37f9ddcbcd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0051-1700000051011 BOTTLE, DROPPER in 1 CARTON (70000-0051-1) / 30 mL in 1 BOTTLE, DROPPER2020-09-020000-00-00NoNoCurrent