Cold Sore Fever Blister Treatment

Product NDC
76162-900
11-digit product format
761620900
Labeler code
76162
Product ID
76162-900_a91e107a-2f8e-4eb3-b1be-e93009f2dba1
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates
Application
ANDA208754
Marketing category
ANDA
Marketing start
2022-01-21
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
76162-900-07Cold Sore Fever Blister Treatment2 g in 1 TUBECREAM23
76162-900-07Cold Sore Fever Blister Treatment1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-900COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [TOPCO ASSOCIATES]2Current NDC, Legacy NDC, 2 package rows20241120_65351744-0438-4416-ae1f-9169fc21d813.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN65351744-0438-4416-ae1f-9169fc21d8133
797534docosanol 100 MG/ML Topical CreamSCD65351744-0438-4416-ae1f-9169fc21d8133
797534docosanol 10 % Topical CreamSY65351744-0438-4416-ae1f-9169fc21d8133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-900-07761620900071 TUBE in 1 PACKAGE (76162-900-07) / 2 g in 1 TUBE1 tube2022-01-210000-00-00NoNoCurrent