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_4048f848-c559-402b-948d-5bbdca0c637e
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-24
Marketing end
2026-10-28
Substance
DIMETHICONE
Active strength
180 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

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
24731f4b-ca2b-483f-beed-dfc8104f8133Available on FDA.report

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.]4Current NDC, Legacy NDC, 1 package rows20240423_24731f4b-ca2b-483f-beed-dfc8104f8133.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 1 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
application number: M002
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
application number: M002
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED322e6cb3-0ddc-9300-e063-6294a90a972a2026-07-31WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
application number: M002
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
application number: M002
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
application number: M002
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
application number: M002
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
application number: M002
Tea Tree Oil AntifungalTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.55a48fc6-1963-66ea-e063-6294a90a35012026-07-02WarningsExact identifier
application number: M002
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
application number: M002
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002

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) 2020-07-242026-10-28NoNoCurrent