Docosanol

Product NDC
72476-965
11-digit product format
724760965
Labeler code
72476
Product ID
72476-965_36285eff-d0bc-4d8e-8243-09fe0dd0fcce
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Care One (Retail Business Services, LLC.)
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
Marketing end
2028-06-30
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-965-07Docosanol2 g in 1 TUBECREAM23
72476-965-07Docosanol1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-965DOCOSANOL CREAM [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]2Current NDC, 2 package rows20240524_9f31b742-4170-4219-80e3-2a5a71b3483e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN9f31b742-4170-4219-80e3-2a5a71b3483e3
797534docosanol 100 MG/ML Topical CreamSCD9f31b742-4170-4219-80e3-2a5a71b3483e3
797534docosanol 10 % Topical CreamSY9f31b742-4170-4219-80e3-2a5a71b3483e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-965-07724760965071 TUBE in 1 PACKAGE (72476-965-07) / 2 g in 1 TUBE1 tube2023-12-312028-06-30NoNoHistorical