FDA.reportPublic FDA data

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

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 Original
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
395be942-d883-4bcb-8811-6fe1521d5a92Available 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

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

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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd346df37d-b0fc-4fa5-8c19-492fed58c2392024-11-25WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONERetail Business Services, LLC.1e8ed36d-5236-163b-e063-6294a90ad6ec2024-11-22WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.0f9639fa-e1d0-460d-bc46-714a01cd98112024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.852cec3b-6564-46b2-afe5-ecef314242372024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.d33e413d-4add-459f-ba46-c23b49cfcc872024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreen Co.d87a20d4-dd1d-4897-9321-f81df2cfbcc72024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.b14b647f-d729-47df-879d-ca08a30b995e2024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWal-Mart Stores Inc206d57ec-c854-496e-af53-7d8b2a208d852024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALGREEN CO.4d523979-e3ae-47e8-9092-00fdffc8bb0b2024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWal-Mart Stores Inc69351cf9-3092-45ca-8b84-83e3737fa8d42024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALMART INC.79a9e0a3-9199-4397-ab29-b8a9c843cdf82024-11-21WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEFOODHOLD U.S.A., LLCc37def6e-bb10-41ba-8bce-b06c09edbe9f2024-11-21WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONE 180 MGHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.2cfb8132-6de4-457d-880b-c870a38862ad2024-11-20WarningsExact identifier
application number: M002
Gas-AidSIMETHICONELeosons Overseas Corpd271bfcb-bf13-4a97-bc03-f1824826f15a2024-11-19WarningsExact identifier
application number: M002
Gas-Aid Drops for infantsSIMETHICONELeosons Overseas Corp06665701-5f1c-4f8f-8775-e0a4a9ef20292024-11-19WarningsExact identifier
application number: M002
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
application number: M002
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
application number: M002
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
application number: M002
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
application number: M002

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