FDA.reportPublic FDA data

Gas Relief

Product NDC
0536-1306
Requested package NDC
0536-1306-08
11-digit product format
005361306
Labeler code
0536
Product ID
0536-1306_aa0ecd91-5bab-4d48-a296-9a8442181561
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-24
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
180 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 packagepackage0536-13060536-1306-08DDiscontinued by firm2026-11-06

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
0536-1306-08Gas ReliefUltra Strength60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1306-08EA - Each0536-1306c6363f4f-d9fb-4f82-9a97-175d5030737e12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1306GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]4Legacy NDC, 1 package rows20240423_24731f4b-ca2b-483f-beed-dfc8104f8133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN24731f4b-ca2b-483f-beed-dfc8104f81336
252294simethicone 180 MG Oral CapsuleSCD24731f4b-ca2b-483f-beed-dfc8104f81336
252294dimethicone 180 MG Oral CapsuleSY24731f4b-ca2b-483f-beed-dfc8104f81336
252294simethicone 180 MG Oral CapsulePSN544106bc-3c80-4d43-9df3-61a931d1751e5
252294simethicone 180 MG Oral CapsuleSCD544106bc-3c80-4d43-9df3-61a931d1751e5
252294dimethicone 180 MG Oral CapsuleSY544106bc-3c80-4d43-9df3-61a931d1751e5
252294simethicone 180 MG Oral CapsulePSN708cbbf2-4923-4cbf-b71c-c8bb2ce80e631
252294simethicone 180 MG Oral CapsuleSCD708cbbf2-4923-4cbf-b71c-c8bb2ce80e631
252294dimethicone 180 MG Oral CapsuleSY708cbbf2-4923-4cbf-b71c-c8bb2ce80e631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1306-080053613060860 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0536-1306-08) 2020-07-240000-00-00NoNoCurrent