Docosanol

Product NDC
21130-770
11-digit product format
211300770
Labeler code
21130
Product ID
21130-770_5a91cc73-e785-4bb5-b76e-e2289ff1789b
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway, Inc.
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
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
21130-770-07Docosanol1 in 1 PACKAGECREAM12
21130-770-07Docosanol2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-770DOCOSANOL CREAM [SAFEWAY, INC.]2Current NDC, 2 package rows20240823_d5ba34f8-42ab-4997-b06b-ea4e754b44d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNd5ba34f8-42ab-4997-b06b-ea4e754b44d12
797534docosanol 100 MG/ML Topical CreamSCDd5ba34f8-42ab-4997-b06b-ea4e754b44d12
797534docosanol 10 % Topical CreamSYd5ba34f8-42ab-4997-b06b-ea4e754b44d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-770-07211300770071 TUBE in 1 PACKAGE (21130-770-07) / 2 g in 1 TUBE1 tube2023-12-31NoNoHistorical