FDA.reportPublic FDA data

Mylicon Infants Gas Relief Dye Free

Product NDC
62372-650
11-digit product format
623720650
Labeler code
62372
Product ID
62372-650_0bb1b812-762c-9bc2-e063-6394a90a79d2
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 Dye Free
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-650-15Mylicon Infants Gas Relief Dye Free15 mL in 1 BOTTLE, DROPPEREMULSION156
62372-650-15Mylicon Infants Gas Relief Dye Free1 in 1 CARTONEMULSION16
62372-650-30Mylicon Infants Gas Relief Dye Free1 in 1 CARTONEMULSION16
62372-650-30Mylicon Infants Gas Relief Dye Free30 mL in 1 BOTTLE, DROPPEREMULSION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-650-30ML - Milliliter62372-650d8654477-8b19-44cf-8e5d-da978627b62912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-650MYLICON INFANTS GAS RELIEF DYE FREE (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]6Current NDC, Legacy NDC, 4 package rows20240111_3324139a-ed22-43af-859d-e7af19a24ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809376MYLICON 20 MG in 0.3 mL Oral SuspensionPSN3324139a-ed22-43af-859d-e7af19a24ee96
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN3324139a-ed22-43af-859d-e7af19a24ee96
809376simethicone 66.7 MG/ML Oral Suspension [Mylicon]SBD3324139a-ed22-43af-859d-e7af19a24ee96
198857simethicone 66.7 MG/ML Oral SuspensionSCD3324139a-ed22-43af-859d-e7af19a24ee96
809376Mylicon 20 MG per 0.3 ML Oral SuspensionSY3324139a-ed22-43af-859d-e7af19a24ee96
809376Mylicon 66.7 MG/ML Oral SuspensionSY3324139a-ed22-43af-859d-e7af19a24ee96
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY3324139a-ed22-43af-859d-e7af19a24ee96
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY3324139a-ed22-43af-859d-e7af19a24ee96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62372-650-15623720650151 BOTTLE, DROPPER in 1 CARTON (62372-650-15) / 15 mL in 1 BOTTLE, DROPPER2015-03-310000-00-00NoNoCurrent
62372-650-30623720650301 BOTTLE, DROPPER in 1 CARTON (62372-650-30) / 30 mL in 1 BOTTLE, DROPPER2015-03-310000-00-00NoNoCurrent