FDA.reportPublic FDA data

INFANT GAS RELIEF

Product NDC
46122-547
11-digit product format
461220547
Labeler code
46122
Product ID
46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
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
INFANT GAS RELIEF
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d3c3cc6-b0a2-620d-e053-2a91aa0a159bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-547-03INFANT GAS RELIEF30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS304
46122-547-03INFANT GAS RELIEF1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-547-03ML - Milliliter46122-54777473185-5c29-4403-a601-f6ffb08e113112020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-547INFANT GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [AMERISOURCEBERGEN DRUG CORPORATION]4Current NDC, Legacy NDC, 2 package rows20231102_7d3c3cc6-b0a2-620d-e053-2a91aa0a159b.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 66.7 MG/ML Oral SuspensionSCD7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7d3c3cc6-b0a2-620d-e053-2a91aa0a159b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-547-03461220547031 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER2018-11-160000-00-00NoNoCurrent