Cold Sore Fever Blister Treatment

Product NDC
21130-605
11-digit product format
211300605
Labeler code
21130
Product ID
21130-605_4914052b-5ef0-47e5-8aae-4922ae8e966a
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway, Inc.
Application
ANDA212385
Marketing category
ANDA
Marketing start
2024-07-31
Marketing end
2026-12-31
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
21130-605-07Cold Sore Fever Blister Treatment2 g in 1 BOTTLE, PUMPCREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-605COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [SAFEWAY, INC.]3Current NDC, 1 package rows20241211_85bfd33e-9404-4483-b76c-0ee519aad731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN85bfd33e-9404-4483-b76c-0ee519aad7314
797534docosanol 100 MG/ML Topical CreamSCD85bfd33e-9404-4483-b76c-0ee519aad7314
797534docosanol 10 % Topical CreamSY85bfd33e-9404-4483-b76c-0ee519aad7314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-605-07211300605072 g in 1 BOTTLE, PUMP (21130-605-07) 2 g2024-07-312026-12-31NoNoHistorical