Gas Relief Simethicone 180mg Softgel

Product NDC
84324-015
11-digit product format
843240015
Labeler code
84324
Product ID
84324-015_9b5943d6-ae9f-44b7-898e-a4a6dd3c7540
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NUVICARE LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
Substance
DIMETHICONE
Active strength
180 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Simethicone 180mg Softgel
Listing expiration
2026-12-31

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
51484644-eb45-4282-91c6-289169bcbaf6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-015-01Gas Relief Simethicone 180mg Softgel100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-015GAS RELIEF SIMETHICONE 180MG SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [NUVICARE LLC]1Current NDC, 1 package rows20240719_51484644-eb45-4282-91c6-289169bcbaf6.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 8 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Gas ReliefSIMETHICONEHarris Teeter, LLC2c3a05de-6690-f49a-e063-6394a90a90852025-02-05WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEHarris Teeter, LLC2c39de90-4896-8a85-e063-6394a90af6772025-02-05WarningsExact identifier
application number: M002
Curist Gas Relief Maximum StrengthSIMETHICONELittle Pharma, Inc.dc15a8e6-8924-f5c2-e053-2a95a90ab2c02025-02-04WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEHarris Teeter, LLC2bd9ebda-520c-691a-e063-6294a90af7d32025-02-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff3b61-8a47-14ec-e053-6294a90a2df82025-01-31WarningsExact identifier
application number: M002
Gas relief Anti-gasSIMETHICONECVS2bc548d2-7176-333b-e063-6394a90aae012025-01-29WarningsExact identifier
application number: M002
Ultrastrength Gas ReliefSIMETHICONE SOFT GELATIN CAPSULESCVS PHARMACY, INC24ceba32-eb30-902f-e063-6394a90a9fd52025-01-29WarningsExact identifier
application number: M002
Extra Strength Gas Relief Cherry CremeSIMETHICONECVS2bc522c8-9df0-05b4-e063-6394a90af60c2025-01-27WarningsExact identifier
application number: M002
HEB Gas Relief Extra Strength PeppermintSIMETHICONEH E B52f6db66-ce4c-40dc-b483-6ba83977cd8b2025-01-20WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEReliable 1 Laboratires LLC330aed4b-7109-09b8-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M002
Simethicone 80 mgSIMETHICONEReliable 1 Laboratories LLC32fb242b-7051-072c-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEAphena Pharma Solutions - Tennessee, LLC5df94be7-0bc9-4be1-9982-8193e3a3c8ef2025-01-10WarningsExact identifier
application number: M002
AntiflatulentSIMETHICONEAphena Pharma Solutions - Tennessee, LLCdd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea2025-01-10WarningsExact identifier
application number: M002
Anti-Gas StripSIMETHICONECalmourc1576ee9-69ff-41ff-b2d0-7703c8fa8edd2025-01-09WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEAMZ789 LLCbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa22025-01-08WarningsExact identifier
application number: M002
Simethicone 250mgSIMETHICONE 250MGAMZ789 LLCfcc2ef8b-9181-2c59-e053-6394a90adcc12025-01-08WarningsExact identifier
application number: M002
extra strength Gas Relief cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC5dcd50ae-370d-4e49-b981-db42b86c2ecb2025-01-01WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONETopco Associates, LLCc90d68a0-22e1-4a37-8487-16ecdc431ede2024-12-26WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN51484644-eb45-4282-91c6-289169bcbaf62
252294simethicone 180 MG Oral CapsuleSCD51484644-eb45-4282-91c6-289169bcbaf62
252294dimethicone 180 MG Oral CapsuleSY51484644-eb45-4282-91c6-289169bcbaf62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84324-015-0184324001501100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-015-01) 2024-07-18NoNoCurrent