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Product NDC
65342-0001
11-digit product format
653420001
Labeler code
65342
Product ID
65342-0001_ba49b2e7-4a21-da17-e053-2995a90a310c
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Gurwitch Products, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-06
Marketing end
2022-12-31
Substance
OCTINOXATE; OCTISALATE
Active strength
55 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65342-0001-02021-02-01C16284748780-1ba0f9c33-49e9-a910-e053-dadaa90a0b85a3552503-f4d9-4703-877e-f33823d8043d
65342-0001-02021-01-29C16284748780-1ba0f9c33-49e9-a910-e053-dadaa90a0b85a3552503-f4d9-4703-877e-f33823d8043d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65342-0001-06534200010050 mL in 1 TUBE (65342-0001-0) 50 ml2013-02-062022-12-31NoNoCurrent