Gas Relief

Product NDC
36800-963
Requested package NDC
36800-963-50
11-digit product format
368000963
Labeler code
36800
Product ID
36800-963_5ef2033d-949f-43d2-993b-2f16729cbaf1
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-30
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 packagepackage36800-96336800-963-50DDiscontinued by firm2026-10-15

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
36800-963-50Gas ReliefUltra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13
36800-963-50Gas ReliefUltra Strength50 in 1 BOXCAPSULE, LIQUID FILLED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-963GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]3Legacy NDC, 2 package rows20241115_3be41f57-862b-472c-97a7-91d0a0a3074b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-963-503680009635050 BLISTER PACK in 1 BOX (36800-963-50) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2020-07-300000-00-00NoNoCurrent