Julie Cold Sore Treatment

Product NDC
82791-362
11-digit product format
827910362
Labeler code
82791
Product ID
82791-362_1d9a1236-b360-4be1-e063-6294a90a27d6
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Julie Products Inc
Application
ANDA217090
Marketing category
ANDA
Marketing start
2024-07-02
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
Julie Cold Sore Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82791-362-01Julie Cold Sore Treatment2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82791-362JULIE COLD SORE TREATMENT (DOCOSANOL) CREAM [JULIE PRODUCTS INC]3Current NDC, 1 package rows20240723_113372a4-58de-f829-e063-6294a90a4eb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN113372a4-58de-f829-e063-6294a90a4eb13
797534docosanol 100 MG/ML Topical CreamSCD113372a4-58de-f829-e063-6294a90a4eb13
797534docosanol 10 % Topical CreamSY113372a4-58de-f829-e063-6294a90a4eb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82791-362-01827910362012 g in 1 TUBE (82791-362-01) 2 g2024-07-02NoNoCurrent