INFANTS GAS RELIEF DROPS

Product NDC
69618-059
11-digit product format
696180059
Labeler code
69618
Product ID
69618-059_0994a4fb-0731-0f98-e063-6394a90a8a58
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
RELIABLE 1 LABORATORIES
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
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
INFANTS 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-059-51INFANTS GAS RELIEF DROPS1 in 1 CARTONSUSPENSION/ DROPS13
69618-059-51INFANTS GAS RELIEF DROPS30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-059INFANTS GAS RELIEF DROPS (SIMETHICONE) SUSPENSION/ DROPS [RELIABLE 1 LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20231108_b479bf22-3469-7916-e053-2995a90addc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSNb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 66.7 MG/ML Oral SuspensionSCDb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 20 MG per 0.3 ML Oral SuspensionSYb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 40 MG per 0.6 ML Oral SuspensionSYb479bf22-3469-7916-e053-2995a90addc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-059-51696180059511 BOTTLE, DROPPER in 1 CARTON (69618-059-51) / 30 mL in 1 BOTTLE, DROPPER2020-02-010000-00-00NoNoCurrent