Docosanol

Product NDC
55301-877
11-digit product format
553010877
Labeler code
55301
Product ID
55301-877_34a6014c-9c19-d22d-e063-6394a90ac32e
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
AAFES/Your Military Exchanges
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-07-01
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
55301-877-07Docosanol1 in 1 PACKAGECREAM14
55301-877-07Docosanol2 g in 1 TUBECREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-877DOCOSANOL CREAM [AAFES/YOUR MILITARY EXCHANGES]4Current NDC, Legacy NDC, 2 package rows20250510_b056ad46-bf48-4468-8b65-9e80176b6c52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNb056ad46-bf48-4468-8b65-9e80176b6c524
797534docosanol 100 MG/ML Topical CreamSCDb056ad46-bf48-4468-8b65-9e80176b6c524
797534docosanol 10 % Topical CreamSYb056ad46-bf48-4468-8b65-9e80176b6c524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-877-07553010877071 TUBE in 1 PACKAGE (55301-877-07) / 2 g in 1 TUBE1 tube2021-07-010000-00-00NoNoCurrent