FDA.reportPublic FDA data

premier value infants gas relief

Product NDC
68016-670
11-digit product format
680160670
Labeler code
68016
Product ID
68016-670_2b8605c2-dcb3-48e0-ac8e-9c583d0a758d
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
Chain Drug Consortium
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-09
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
premier value infants gas relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-670-00premier value infants gas relief1 in 1 CARTONEMULSION18
68016-670-00premier value infants gas relief30 mL in 1 BOTTLE, DROPPEREMULSION308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7PREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
SORBITOLINACTIVE INGREDIENT506T60A25RPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1
WATERINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-670PREMIER VALUE INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG CONSORTIUM]8Current NDC, Legacy NDC, 2 package rows20241030_7b887e53-a70a-4f33-9472-e1175b24400a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7b887e53-a70a-4f33-9472-e1175b24400a8
198857simethicone 66.7 MG/ML Oral SuspensionSCD7b887e53-a70a-4f33-9472-e1175b24400a8
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7b887e53-a70a-4f33-9472-e1175b24400a8
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7b887e53-a70a-4f33-9472-e1175b24400a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-670-00680160670001 BOTTLE, DROPPER in 1 CARTON (68016-670-00) / 30 mL in 1 BOTTLE, DROPPER2015-01-090000-00-00NoNoCurrent