Cold Sore Fever Blister Treatment

Product NDC
81522-112
11-digit product format
815220112
Labeler code
81522
Product ID
81522-112_788e64c2-c330-4488-aa87-35fdd7fed014
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
FSA Store Inc. (Caring Mills)
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
Marketing end
2027-08-28
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sore Fever Blister Treatment

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
81522-112-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM24
81522-112-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-112COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [FSA STORE INC. (CARING MILLS)]3Current NDC, 2 package rows20240127_fe67f56e-4c35-40cb-8a75-174a873f2900.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNfe67f56e-4c35-40cb-8a75-174a873f29004
797534docosanol 100 MG/ML Topical CreamSCDfe67f56e-4c35-40cb-8a75-174a873f29004
797534docosanol 10 % Topical CreamSYfe67f56e-4c35-40cb-8a75-174a873f29004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81522-112-07815220112071 TUBE in 1 PACKAGE (81522-112-07) / 2 g in 1 TUBE1 tube2023-12-312027-08-28NoNoHistorical