FDA.reportPublic FDA data

Maximum Strength Gas Relief

Product NDC
11822-1570
Requested package NDC
11822-1570-6
11-digit product format
118221570
Labeler code
11822
Product ID
11822-1570_ee4fd107-9c7d-14e2-e053-2995a90a544c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RITE AID CORPORATION
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-12-09
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-157011822-1570-6IInactivated by FDA2026-10-20

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1570-6Maximum Strength Gas Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1570MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]5Legacy NDC, 1 package rows20250101_5094ac34-d309-4729-9826-e0b262185b45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN5094ac34-d309-4729-9826-e0b262185b455
412111simethicone 250 MG Oral CapsuleSCD5094ac34-d309-4729-9826-e0b262185b455
412111dimethicone 250 MG Oral CapsuleSY5094ac34-d309-4729-9826-e0b262185b455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-1570-61182215700660 CAPSULE, LIQUID FILLED in 1 BOTTLE (11822-1570-6) 2021-12-090000-00-00NoNoCurrent