Docosanol

Product NDC
79903-402
11-digit product format
799030402
Labeler code
79903
Product ID
79903-402_11c523b3-31ec-4873-8e24-1c62e714175c
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
WALMART INC. (see also Equate)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2025-11-15
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docosanol
Listing expiration
2027-12-31

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
79903-402-10Docosanol1 in 1 PACKAGECREAM12
79903-402-10Docosanol2 g in 1 TUBECREAM22
79903-402-20Docosanol2 g in 1 TUBECREAM22
79903-402-20Docosanol2 in 1 PACKAGECREAM22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN45cfa88b-8146-4349-99cc-beec704557092
797534docosanol 100 MG/ML Topical CreamSCD45cfa88b-8146-4349-99cc-beec704557092
797534docosanol 10 % Topical CreamSY45cfa88b-8146-4349-99cc-beec704557092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-402-10799030402101 TUBE in 1 PACKAGE (79903-402-10) / 2 g in 1 TUBE1 tube2025-11-15NoNoCurrent
79903-402-20799030402202 TUBE in 1 PACKAGE (79903-402-20) / 2 g in 1 TUBE2 tube2025-11-15NoNoCurrent