INFANT GAS RELIEF

Product NDC
46122-547
11-digit product format
461220547
Labeler code
46122
Product ID
46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
Substance
DIMETHICONE
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
INFANT GAS RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-547-03INFANT GAS RELIEF30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS304
46122-547-03INFANT GAS RELIEF1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-547INFANT GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [AMERISOURCEBERGEN DRUG CORPORATION]4Current NDC, Legacy NDC, 2 package rows20231102_7d3c3cc6-b0a2-620d-e053-2a91aa0a159b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 66.7 MG/ML Oral SuspensionSCD7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-547-03461220547031 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER2018-11-160000-00-00NoNoCurrent