Simethicone

Product NDC
73629-002
11-digit product format
736290002
Labeler code
73629
Product ID
73629-002_2b3b1754-50af-4089-e063-6294a90a4e75
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AMZ789 LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui252294

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73629-002-182023-05-28C16284748780-1e4f33bdf-a050-d8a0-e053-dadaa90a6e4eSimethicone 180mg
73629-002-182022-07-29C16284748780-1e4f33bdf-a050-d8a0-e053-dadaa90a6e4eSimethicone 180mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73629-002-18Simethicone180 in 1 BOTTLECAPSULE, LIQUID FILLED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73629-002SIMETHICONE CAPSULE, LIQUID FILLED [AMZ789 LLC]4Current NDC, Legacy NDC, 1 package rows20250110_bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSNbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa24
252294simethicone 180 MG Oral CapsuleSCDbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa24
252294dimethicone 180 MG Oral CapsuleSYbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73629-002-1873629000218180 CAPSULE, LIQUID FILLED in 1 BOTTLE (73629-002-18) 2021-05-010000-00-00NoNoCurrent
73629-002-2273629000222220 CAPSULE, LIQUID FILLED in 1 BOTTLE (73629-002-22) 2021-05-010000-00-00NoNoCurrent