EXTRA STRENGTH

Product NDC
55505-225
11-digit product format
555050225
Labeler code
55505
Product ID
55505-225_f182e0fd-db67-4eab-9db4-faedcff42eee
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
LIQUID
Route
ORAL
Labeler
KRAMER LABORATORIES
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-26
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 mg/5mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EXTRA STRENGTH
Brand name suffix
gas relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui2262288

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-225-36EXTRA STRENGTHgas relief237 mL in 1 BOTTLELIQUID2374
55505-225-83EXTRA STRENGTHgas relief2 in 1 PACKAGELIQUID24
55505-225-83EXTRA STRENGTHgas relief237 mL in 1 BOTTLELIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-225EXTRA STRENGTH GAS RELIEF (SIMETHICONE) LIQUID [KRAMER LABORATORIES]3Current NDC, 3 package rows20250419_d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2262288simethicone 125 MG in 5 mL Oral SuspensionPSNd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb4
2262288simethicone 25 MG/ML Oral SuspensionSCDd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb4
2262288simethicone 125 MG per 5 ML Oral SuspensionSYd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55505-225-3655505022536237 mL in 1 BOTTLE (55505-225-36) 237 ml2023-11-03NoNoHistorical
55505-225-83555050225832 BOTTLE in 1 PACKAGE (55505-225-83) / 237 mL in 1 BOTTLE2 bottle2025-05-01NoNoHistorical