Docosanol

Product NDC
72476-492
11-digit product format
724760492
Labeler code
72476
Product ID
72476-492_7647f893-702f-486f-92d4-5b7cccd2d714
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Care One (Retail Business Services, LLC.)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2020-11-27
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 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
72476-492-07Docosanol2 g in 1 TUBECREAM22
72476-492-07Docosanol1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-492DOCOSANOL CREAM [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]2Current NDC, Legacy NDC, 2 package rows20221022_3587f8f0-99ab-4493-adde-0dfd0911170d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN3587f8f0-99ab-4493-adde-0dfd0911170d2
797534docosanol 100 MG/ML Topical CreamSCD3587f8f0-99ab-4493-adde-0dfd0911170d2
797534docosanol 10 % Topical CreamSY3587f8f0-99ab-4493-adde-0dfd0911170d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-492-07724760492071 TUBE in 1 PACKAGE (72476-492-07) / 2 g in 1 TUBE1 tube2020-11-270000-00-00NoNoCurrent