Docosanol

Product NDC
62011-0433
11-digit product format
620110433
Labeler code
62011
Product ID
62011-0433_5174f877-30bf-47d7-8b88-0b34f713e1a0
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA208754
Marketing category
ANDA
Marketing start
2019-10-30
Marketing end
2026-12-30
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docosanol

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
62011-0433-1Docosanol2 g in 1 TUBECREAM24
62011-0433-1Docosanol1 in 1 PACKAGECREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0433-1GM - Gram62011-04334ae64934-2bca-45bd-848b-2249b695f9a112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0433DOCOSANOL CREAM [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20231021_3faf583c-90d2-4620-93ea-d763191ab452.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN3faf583c-90d2-4620-93ea-d763191ab4524
797534docosanol 100 MG/ML Topical CreamSCD3faf583c-90d2-4620-93ea-d763191ab4524
797534docosanol 10 % Topical CreamSY3faf583c-90d2-4620-93ea-d763191ab4524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0433-1620110433011 TUBE in 1 PACKAGE (62011-0433-1) / 2 g in 1 TUBE1 tube2019-10-302026-12-30NoNoCurrent