Gas Relief

Product NDC
59726-773
11-digit product format
597260773
Labeler code
59726
Product ID
59726-773_88702ff5-f43b-46b7-a52d-381ce700860b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-27
Marketing end
2026-12-31
Substance
DIMETHICONE
Active strength
180 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59726-773-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59726-773-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59726-773-20bd6a592717d7…303034d00443…

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
Gas Relief
Brand name suffix
Ultra Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 mg/1

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
252294Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc2dd74a-9cdb-4162-9d05-2b9279f4a38eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-773-202023-10-16C16284748780-1d6a99b39-aa8c-a426-e053-dadaa90af4c2Drug Facts
59726-773-202022-01-28C16284748780-1d6a99b39-aa8c-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-773-20Gas ReliefUltra Strength20 in 1 CARTONCAPSULE, LIQUID FILLED203
59726-773-20Gas ReliefUltra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-773GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]2Current NDC, Legacy NDC, 2 package rows20231017_cc2dd74a-9cdb-4162-9d05-2b9279f4a38e.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 11 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
application number: M002
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
application number: M002
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
application number: M002
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreensaa074ceb-b86e-4a07-b885-b8fa6c1e0fcf2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens3e5821ec-d096-4f52-82d2-475056f45e4c2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens0050b639-5fb6-4503-ae73-e319cf0370272024-06-26WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC853f5f52-8fe1-473f-b68d-2951152221202024-05-31WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEA-S Medication Solutions708cbbf2-4923-4cbf-b71c-c8bb2ce80e632024-05-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIa7961933-9d74-4c18-8050-2cc13cb6725e2024-05-23WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONESafeway, Inc.8927d9eb-65b2-40f3-846c-dc9cd2884dea2024-05-14WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff50f5-4195-a61f-e053-6294a90a8bdf2024-05-13WarningsExact identifier
application number: M002
simethicone gas reliefSIMETHICONEMOM Enterprises, LCC536ecfdf-7124-502a-e054-00144ff8d46c2024-04-09WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSNcc2dd74a-9cdb-4162-9d05-2b9279f4a38e3
252294simethicone 180 MG Oral CapsuleSCDcc2dd74a-9cdb-4162-9d05-2b9279f4a38e3
252294dimethicone 180 MG Oral CapsuleSYcc2dd74a-9cdb-4162-9d05-2b9279f4a38e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-773-205972607732020 BLISTER PACK in 1 CARTON (59726-773-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK20 blister pack2020-03-272026-12-31NoNoCurrent