Maximum Strength Gas Relief Softgel-60ct

Product NDC
37808-813
11-digit product format
378080813
Labeler code
37808
Product ID
37808-813_35e27c03-8b87-4436-abef-6ff4b21ee1fe
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HEB
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-16
Substance
DIMETHICONE, UNSPECIFIED
Active strength
250 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
Maximum Strength Gas Relief Softgel-60ct
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED250 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
412111Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f65e362a-2f90-428a-b885-eefdad8cae1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-813-06Maximum Strength Gas Relief Softgel-60ct1 in 1 CARTONCAPSULE, LIQUID FILLED13
37808-813-06Maximum Strength Gas Relief Softgel-60ct60 in 1 BOTTLECAPSULE, LIQUID FILLED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-813MAXIMUM STRENGTH GAS RELIEF SOFTGEL-60CT (SIMETHICONE) CAPSULE, LIQUID FILLED [HEB]3Current NDC, 2 package rows20250109_f65e362a-2f90-428a-b885-eefdad8cae1e.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSNf65e362a-2f90-428a-b885-eefdad8cae1e3
412111simethicone 250 MG Oral CapsuleSCDf65e362a-2f90-428a-b885-eefdad8cae1e3
412111dimethicone 250 MG Oral CapsuleSYf65e362a-2f90-428a-b885-eefdad8cae1e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-813-06378080813061 BOTTLE in 1 CARTON (37808-813-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-02-16NoNoCurrent