Mylicon Infants Gas Relief Original

Product NDC
62372-630
11-digit product format
623720630
Labeler code
62372
Product ID
62372-630_0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
Infirst Healthcare
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
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
Mylicon Infants Gas Relief Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857, 809376

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
62372-630-15Mylicon Infants Gas Relief Original1 in 1 CARTONEMULSION15
62372-630-15Mylicon Infants Gas Relief Original15 mL in 1 BOTTLE, DROPPEREMULSION155
62372-630-30Mylicon Infants Gas Relief Original30 mL in 1 BOTTLE, DROPPEREMULSION305
62372-630-30Mylicon Infants Gas Relief Original1 in 1 CARTONEMULSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-630-15ML - Milliliter62372-63097aa3541-8331-4428-a14b-bfb2273cacde12020-04-20
62372-630-30ML - Milliliter62372-6300847b805-d89b-4932-8302-166975f4c65512021-10-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
SORBITOLINACTIVE INGREDIENT506T60A25RMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
WATERINACTIVE INGREDIENT059QF0KO0RMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-630MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]5Current NDC, Legacy NDC, 4 package rows20240111_395be942-d883-4bcb-8811-6fe1521d5a92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809376MYLICON 20 MG in 0.3 mL Oral SuspensionPSN395be942-d883-4bcb-8811-6fe1521d5a925
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN395be942-d883-4bcb-8811-6fe1521d5a925
809376simethicone 66.7 MG/ML Oral Suspension [Mylicon]SBD395be942-d883-4bcb-8811-6fe1521d5a925
198857simethicone 66.7 MG/ML Oral SuspensionSCD395be942-d883-4bcb-8811-6fe1521d5a925
809376Mylicon 20 MG per 0.3 ML Oral SuspensionSY395be942-d883-4bcb-8811-6fe1521d5a925
809376Mylicon 66.7 MG/ML Oral SuspensionSY395be942-d883-4bcb-8811-6fe1521d5a925
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY395be942-d883-4bcb-8811-6fe1521d5a925
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY395be942-d883-4bcb-8811-6fe1521d5a925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62372-630-15623720630151 BOTTLE, DROPPER in 1 CARTON (62372-630-15) / 15 mL in 1 BOTTLE, DROPPER2015-03-310000-00-00NoNoCurrent
62372-630-30623720630301 BOTTLE, DROPPER in 1 CARTON (62372-630-30) / 30 mL in 1 BOTTLE, DROPPER2015-03-310000-00-00NoNoCurrent