FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
DOCOSANOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-019-08DOCOSANOL2 g in 1 TUBECREAM22
58602-019-08DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-09DOCOSANOL2 g in 1 TUBECREAM22
58602-019-09DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-11DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-11DOCOSANOL3 g in 1 TUBECREAM32
58602-019-12DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-12DOCOSANOL3 g in 1 TUBECREAM32
58602-019-13DOCOSANOL3 g in 1 TUBECREAM32
58602-019-13DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-15DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-15DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-16DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-16DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-17DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-17DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-24DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-24DOCOSANOL2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-019DOCOSANOL CREAM [AUROHEALTH LLC]2Current NDC, 18 package rows20240823_9f361f24-a0a1-4e43-a158-8c830c9adca7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN9f361f24-a0a1-4e43-a158-8c830c9adca72
797534docosanol 100 MG/ML Topical CreamSCD9f361f24-a0a1-4e43-a158-8c830c9adca72
797534docosanol 10 % Topical CreamSY9f361f24-a0a1-4e43-a158-8c830c9adca72

Packages#

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