ULTRA STRENGTH Gas Relief Softgels

Product NDC
76162-840
11-digit product format
761620840
Labeler code
76162
Product ID
76162-840_acddc122-3fe4-4a46-ae05-463ed8e16257
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-17
Substance
DIMETHICONE, UNSPECIFIED
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

Additional Listing Data#

Finished product
Yes
Brand name base
ULTRA STRENGTH Gas Relief Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui252294

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-840-05ULTRA STRENGTH Gas Relief Softgels25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED252
76162-840-05ULTRA STRENGTH Gas Relief Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN42c449cc-a450-1796-e063-6294a90a762a2
252294simethicone 180 MG Oral CapsuleSCD42c449cc-a450-1796-e063-6294a90a762a2
252294dimethicone 180 MG Oral CapsuleSY42c449cc-a450-1796-e063-6294a90a762a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-840-05761620840052 BLISTER PACK in 1 CARTON (76162-840-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-12-17NoNoCurrent