Cold Sore Fever Blister Treatment

Product NDC
81522-923
11-digit product format
815220923
Labeler code
81522
Product ID
81522-923_7a7cb11e-f748-4ece-be37-15686e9c4e1c
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
FSA Store Inc. (Caring Mills)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-10-08
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
81522-923-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM22
81522-923-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-923COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [FSA STORE INC. (CARING MILLS)]2Current NDC, Legacy NDC, 2 package rows20221202_c17cc31f-bd2e-4da2-bba4-54b6b8b1ebf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNc17cc31f-bd2e-4da2-bba4-54b6b8b1ebf72
797534docosanol 100 MG/ML Topical CreamSCDc17cc31f-bd2e-4da2-bba4-54b6b8b1ebf72
797534docosanol 10 % Topical CreamSYc17cc31f-bd2e-4da2-bba4-54b6b8b1ebf72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81522-923-07815220923071 TUBE in 1 PACKAGE (81522-923-07) / 2 g in 1 TUBE1 tube2021-10-080000-00-00NoNoCurrent