Cold Sore Fever Blister Treatment

Product NDC
21130-823
11-digit product format
211300823
Labeler code
21130
Product ID
21130-823_bafa9a8e-b29e-48c1-b4e3-c4cc1d300f6b
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway, Inc.
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-07-30
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
Cold Sore Fever Blister Treatment
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
21130-823-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM23
21130-823-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-823COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [SAFEWAY, INC.]3Current NDC, Legacy NDC, 2 package rows20240823_5871e578-d16e-4f07-a32e-5263f9ca0a6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN5871e578-d16e-4f07-a32e-5263f9ca0a6a3
797534docosanol 100 MG/ML Topical CreamSCD5871e578-d16e-4f07-a32e-5263f9ca0a6a3
797534docosanol 10 % Topical CreamSY5871e578-d16e-4f07-a32e-5263f9ca0a6a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-823-07211300823071 TUBE in 1 PACKAGE (21130-823-07) / 2 g in 1 TUBE1 tube2021-07-300000-00-00NoNoCurrent