Docosanol

Product NDC
72476-922
11-digit product format
724760922
Labeler code
72476
Product ID
72476-922_ca6bd819-d850-4d5d-b213-c27f8f858749
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
2020-06-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-922-072023-10-05C16284748780-1f386c64a-06b6-0266-e053-dadaa90a7c1aDocosanol Cream, 10%
72476-922-072023-01-30C16284748780-1f386c64a-06b6-0266-e053-dadaa90a7c1aDocosanol Cream, 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-922-07Docosanol1 in 1 PACKAGECREAM13
72476-922-07Docosanol2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-922DOCOSANOL CREAM [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]3Current NDC, Legacy NDC, 2 package rows20231006_c3f386e2-68da-4d64-809a-e170d473731d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNc3f386e2-68da-4d64-809a-e170d473731d3
797534docosanol 100 MG/ML Topical CreamSCDc3f386e2-68da-4d64-809a-e170d473731d3
797534docosanol 10 % Topical CreamSYc3f386e2-68da-4d64-809a-e170d473731d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-922-07724760922071 TUBE in 1 PACKAGE (72476-922-07) / 2 g in 1 TUBE1 tube2020-06-300000-00-00NoNoCurrent