Maximum Strength Gas Relief

Product NDC
63868-975
11-digit product format
638680975
Labeler code
63868
Product ID
63868-975_887f0f64-c695-457a-9310-8dfbb55bf792
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-28
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
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
e8b2c528-121d-519a-e053-2a95a90a4119Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-975-06Maximum Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14
63868-975-06Maximum Strength Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-975MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]4Current NDC, 2 package rows20250101_e8b2c528-121d-519a-e053-2a95a90a4119.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 CapsulePSNe8b2c528-121d-519a-e053-2a95a90a41194
412111simethicone 250 MG Oral CapsuleSCDe8b2c528-121d-519a-e053-2a95a90a41194
412111dimethicone 250 MG Oral CapsuleSYe8b2c528-121d-519a-e053-2a95a90a41194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63868-975-06638680975061 BOTTLE, PLASTIC in 1 CARTON (63868-975-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-03-28NoNoCurrent