FDA.reportPublic FDA data

Meijer Infants Gas Relief Drops

Product NDC
41250-470
11-digit product format
412500470
Labeler code
41250
Product ID
41250-470_41f2495b-ab5f-e0c8-e063-6394a90a5a6b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-29
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
Meijer Infants Gas Relief Drops
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-470-01Meijer Infants Gas Relief Drops1 in 1 CARTONEMULSION17
41250-470-01Meijer Infants Gas Relief Drops30 mL in 1 BOTTLEEMULSION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-470MEIJER INFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [MEIJER DISTRIBUTION INC.]6Current NDC, Legacy NDC, 2 package rows20241020_4493efcd-a547-4700-9e6a-a67d6420edb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN4493efcd-a547-4700-9e6a-a67d6420edb57
198857simethicone 66.7 MG/ML Oral SuspensionSCD4493efcd-a547-4700-9e6a-a67d6420edb57
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY4493efcd-a547-4700-9e6a-a67d6420edb57
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY4493efcd-a547-4700-9e6a-a67d6420edb57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-470-01412500470011 BOTTLE in 1 CARTON (41250-470-01) / 30 mL in 1 BOTTLE1 bottle2020-06-290000-00-00NoNoCurrent