FDA.reportPublic FDA data

Infants Gas relief

Product NDC
79481-0011
11-digit product format
794810011
Labeler code
79481
Product ID
79481-0011_fe4b7176-fda5-4eed-ad9e-fa0e154e9cca
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Meijer, Inc.
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-01-18
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
20 mg/.3mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79481-0011DDiscontinued by firm2026-10-20
excluded packagepackage79481-001179481-0011-9DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct79481-0011DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage79481-001179481-0011-9DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0011INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [MEIJER, INC.]4Legacy NDC20241211_e3e28a2e-8e95-4513-be78-5e930e63412f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79481-0011-9794810011091 BOTTLE, DROPPER in 1 CARTON (79481-0011-9) > 30 mL in 1 BOTTLE, DROPPER2022-01-180000-00-00NoNoCurrent