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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198857Internal RxNorm lookup
809376Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3324139a-ed22-43af-859d-e7af19a24ee9Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
application number: M002
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
application number: M002
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
application number: M002
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreensaa074ceb-b86e-4a07-b885-b8fa6c1e0fcf2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens3e5821ec-d096-4f52-82d2-475056f45e4c2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens0050b639-5fb6-4503-ae73-e319cf0370272024-06-26WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC853f5f52-8fe1-473f-b68d-2951152221202024-05-31WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEA-S Medication Solutions708cbbf2-4923-4cbf-b71c-c8bb2ce80e632024-05-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIa7961933-9d74-4c18-8050-2cc13cb6725e2024-05-23WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONESafeway, Inc.8927d9eb-65b2-40f3-846c-dc9cd2884dea2024-05-14WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff50f5-4195-a61f-e053-6294a90a8bdf2024-05-13WarningsExact identifier
application number: M002
simethicone gas reliefSIMETHICONEMOM Enterprises, LCC536ecfdf-7124-502a-e054-00144ff8d46c2024-04-09WarningsExact identifier
application number: M002

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