FDA.reportPublic FDA data

Infants Gas Relief Drops

Product NDC
15127-042
11-digit product format
151270042
Labeler code
15127
Product ID
15127-042_0f3c6d9c-2054-42b3-820b-dd2d32e6fe3c
Type
HUMAN OTC DRUG
Nonproprietary name
simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
Select Brand
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-02
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
20 mg/.3mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15127-042-172020-01-31C16284748780-19d75b9d0-e986-f424-e053-dadaa90a57ceSelect Brand Infant's Gas Relief Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-042-17Infants Gas Relief Drops1 in 1 CARTONEMULSION11
15127-042-17Infants Gas Relief Drops30 mL in 1 BOTTLE, DROPPEREMULSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15127-042-17ML - Milliliter15127-042dad3aaa8-9bdc-4071-9422-46ec09af7e3012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-042INFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [SELECT BRAND]1Legacy NDC, 2 package rows20141002_96612f9b-aa15-4ef5-9ec4-eab44f3c69c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN96612f9b-aa15-4ef5-9ec4-eab44f3c69c71
198857simethicone 66.7 MG/ML Oral SuspensionSCD96612f9b-aa15-4ef5-9ec4-eab44f3c69c71
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY96612f9b-aa15-4ef5-9ec4-eab44f3c69c71
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY96612f9b-aa15-4ef5-9ec4-eab44f3c69c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
15127-042-17151270042171 in 1 CARTONHistorical