FDA.reportPublic FDA data

SIMETHICONE INFANT

Product NDC
82568-0017
11-digit product format
825680017
Labeler code
82568
Product ID
82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
AARNA USA Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-20
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
SIMETHICONE INFANT
Brand name suffix
Gas Relief Drops
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
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
82568-0017-3SIMETHICONE INFANTGas Relief Drops1 in 1 PACKAGESUSPENSION13
82568-0017-3SIMETHICONE INFANTGas Relief Drops30 mL in 1 BOTTLESUSPENSION303
82568-0017-4SIMETHICONE INFANTGas Relief Drops118 mL in 1 BOTTLESUSPENSION1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0017-3ML - Milliliter82568-0017b5bb14da-65f2-41ba-89f9-e1555f0e1b5612025-10-14
82568-0017-4ML - Milliliter82568-0017c1386582-32de-40f1-8f29-0a70ca9eb35e12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0017SIMETHICONE INFANT GAS RELIEF DROPS (SIMETHICONE) SUSPENSION [AARNA USA INC.]1Current NDC, 3 package rows20250303_9b0fde90-35ae-498e-99cc-d120f1a87182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 66.7 MG/ML Oral SuspensionSCD410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 66.7 MG/ML Oral SuspensionSCD9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 66.7 MG/ML Oral SuspensionSCD4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY4d658287-358f-d358-e063-6294a90a4bd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0017-3825680017031 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE1 bottle2025-02-20NoNoHistorical
82568-0017-482568001704118 mL in 1 BOTTLE (82568-0017-4) 118 ml2025-02-20NoNoHistorical