Docosanol

Product NDC
70000-0672
11-digit product format
700000672
Labeler code
70000
Product ID
70000-0672_439fd725-9dc5-4808-955f-1a855adb4cc7
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Leader/ Cardinal Health 110, Inc.
Application
ANDA215839
Marketing category
ANDA
Marketing start
2024-05-22
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0672-1Docosanol2 g in 1 TUBECREAM22
70000-0672-1Docosanol1 in 1 PACKAGECREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0672-1GM - Gram70000-0672e55bc92c-ef93-4e2f-8925-02bb6c58834e12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0672DOCOSANOL CREAM [LEADER/ CARDINAL HEALTH 110, INC.]1Current NDC, 2 package rows20240523_ed18ecb7-70ce-4037-a738-6b159e364d62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNed18ecb7-70ce-4037-a738-6b159e364d622
797534docosanol 100 MG/ML Topical CreamSCDed18ecb7-70ce-4037-a738-6b159e364d622
797534docosanol 10 % Topical CreamSYed18ecb7-70ce-4037-a738-6b159e364d622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0672-1700000672011 TUBE in 1 PACKAGE (70000-0672-1) / 2 g in 1 TUBE1 tube2024-05-22NoNoCurrent