FDA.reportPublic FDA data

Delice

Product NDC
82160-351
11-digit product format
821600351
Labeler code
82160
Product ID
82160-351_d393e6b1-6c7a-065f-e053-2a95a90a0029
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-19
Marketing end
0000-00-00
Substance
DIMETHICONE; DIMETHICONE 100
Active strength
21 g/50mL; g/50mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82160-351IInactivated by FDA2026-08-10
excluded packagepackage82160-35182160-351-01IInactivated by FDA2026-08-10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-351-01Delice50 mL in 1 BOTTLE, GLASSSOLUTION50354
82160-351-01Delice1 in 1 CARTONSOLUTION1354

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-351DELICE (DIMETHICONE) SOLUTION [PELLA PHARMACEUTICALS CO. LTD]354Legacy NDC, 2 package rows20250101_d0bf7f31-5208-3118-e053-2a95a90a27b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82160-351-01821600351011 BOTTLE, GLASS in 1 CARTON (82160-351-01) > 50 mL in 1 BOTTLE, GLASS2011-09-190000-00-00NoNoCurrent