Infants Gas relief

Product NDC
41163-096
11-digit product format
411630096
Labeler code
41163
Product ID
41163-096_4780240f-e434-439b-bfc2-4d434e9f61c3
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
UNITED NATURAL FOODS, INC. DBA UNFI
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-26
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
Infants Gas relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-096-09Infants Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
41163-096-09Infants Gas relief1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-096INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC. DBA UNFI]2Current NDC, Legacy NDC, 2 package rows20241222_a9902ba0-f239-4e66-8d66-7cef39a5fdc3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-096-09411630096091 BOTTLE, DROPPER in 1 CARTON (41163-096-09) / 30 mL in 1 BOTTLE, DROPPER2021-08-260000-00-00NoNoCurrent