Cold Sore Fever Blister Treatment

Product NDC
76162-818
11-digit product format
761620818
Labeler code
76162
Product ID
76162-818_12928119-fbf0-4732-9e4f-b77ab18304eb
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
Marketing end
2028-06-30
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
76162-818-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM13
76162-818-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-818COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [TOPCO ASSOCIATES]2Current NDC, 2 package rows20240406_73348ce7-5b08-49ad-ba59-6f54887f819b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN73348ce7-5b08-49ad-ba59-6f54887f819b3
797534docosanol 100 MG/ML Topical CreamSCD73348ce7-5b08-49ad-ba59-6f54887f819b3
797534docosanol 10 % Topical CreamSY73348ce7-5b08-49ad-ba59-6f54887f819b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-818-07761620818071 TUBE in 1 PACKAGE (76162-818-07) / 2 g in 1 TUBE1 tube2023-12-312028-06-30NoNoHistorical