Cold Sore Fever Blister

Product NDC
37808-223
11-digit product format
378080223
Labeler code
37808
Product ID
37808-223_8b595acd-7818-4061-970f-e1b64f3e8284
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
ANDA208754
Marketing category
ANDA
Marketing start
2021-08-01
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
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
37808-223-07Cold Sore Fever Blister1 in 1 PACKAGECREAM14
37808-223-07Cold Sore Fever Blister2 g in 1 TUBECREAM24
37808-223-14Cold Sore Fever Blister2 g in 1 TUBECREAM24
37808-223-14Cold Sore Fever Blister2 in 1 PACKAGECREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-223COLD SORE FEVER BLISTER (DOCOSANOL) CREAM [H E B]4Current NDC, Legacy NDC, 4 package rows20231013_d9c5f237-62a2-4cba-920d-2c7aa0434b0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNd9c5f237-62a2-4cba-920d-2c7aa0434b0e4
797534docosanol 100 MG/ML Topical CreamSCDd9c5f237-62a2-4cba-920d-2c7aa0434b0e4
797534docosanol 10 % Topical CreamSYd9c5f237-62a2-4cba-920d-2c7aa0434b0e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-223-07378080223071 TUBE in 1 PACKAGE (37808-223-07) / 2 g in 1 TUBE1 tube2021-08-010000-00-00NoNoCurrent
37808-223-14378080223142 TUBE in 1 PACKAGE (37808-223-14) / 2 g in 1 TUBE2 tube2021-08-010000-00-00NoNoCurrent