Docosanol

Product NDC
21130-422
11-digit product format
211300422
Labeler code
21130
Product ID
21130-422_0ad190c5-45b4-4d66-8c98-8ed2759420d7
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway, Inc.
Application
ANDA208754
Marketing category
ANDA
Marketing start
2020-08-11
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
21130-422-07Docosanol2 g in 1 TUBECREAM23
21130-422-07Docosanol1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-422DOCOSANOL CREAM [SAFEWAY, INC.]3Current NDC, Legacy NDC, 2 package rows20230105_8899d833-581c-49af-8d27-c67c633d72d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN8899d833-581c-49af-8d27-c67c633d72d03
797534docosanol 100 MG/ML Topical CreamSCD8899d833-581c-49af-8d27-c67c633d72d03
797534docosanol 10 % Topical CreamSY8899d833-581c-49af-8d27-c67c633d72d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-422-07211300422071 TUBE in 1 PACKAGE (21130-422-07) / 2 g in 1 TUBE1 tube2020-08-110000-00-00NoNoCurrent