DOCOSANOL

Product NDC
58602-019
11-digit product format
586020019
Labeler code
58602
Product ID
58602-019_a0ddfc5f-c31c-4615-9545-11777b318454
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA217090
Marketing category
ANDA
Marketing start
2024-03-01
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9G1OE216XYDOCOSANOL661-19-8DOCOSANOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-019-08586020019081 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE1 tube2024-03-01NoNoHistorical
58602-019-09586020019092 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE2 tube2024-03-01NoNoHistorical
58602-019-11586020019111 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE1 tube2024-03-01NoNoHistorical
58602-019-12586020019121 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE1 tube2024-03-01NoNoHistorical
58602-019-13586020019132 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE2 tube2024-03-01NoNoHistorical
58602-019-15586020019151 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoHistorical
58602-019-16586020019161 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoHistorical
58602-019-17586020019172 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoHistorical
58602-019-24586020019241 TUBE in 1 PACKAGE (58602-019-24) / 2 g in 1 TUBE1 tube2024-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DOCOSANOL - Aurohealth LLC | APL HEALTHCARE LIMITEDAurohealth LLC | APL HEALTHCARE LIMITED2024-08-16Human OTC Drug Label2