Cold Sore Fever Blister

Product NDC
37808-661
11-digit product format
378080661
Labeler code
37808
Product ID
37808-661_94d4fe1d-4c25-4fc9-b6f4-b2f6436a0cbf
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
ANDA212385
Marketing category
ANDA
Marketing start
2023-12-31
Marketing end
2028-01-31
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

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
37808-661-07Cold Sore Fever Blister2 g in 1 TUBECREAM25
37808-661-07Cold Sore Fever Blister1 in 1 PACKAGECREAM15
37808-661-14Cold Sore Fever Blister2 in 1 PACKAGECREAM25
37808-661-14Cold Sore Fever Blister2 g in 1 TUBECREAM25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-661COLD SORE FEVER BLISTER (DOCOSANOL) CREAM [H E B]4Current NDC, 4 package rows20240927_71b2bb18-4a48-42c2-b03a-dccf581a0d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN71b2bb18-4a48-42c2-b03a-dccf581a0d975
797534docosanol 100 MG/ML Topical CreamSCD71b2bb18-4a48-42c2-b03a-dccf581a0d975
797534docosanol 10 % Topical CreamSY71b2bb18-4a48-42c2-b03a-dccf581a0d975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-661-07378080661071 TUBE in 1 PACKAGE (37808-661-07) / 2 g in 1 TUBE1 tube2023-12-312028-01-31NoNoHistorical
37808-661-14378080661142 TUBE in 1 PACKAGE (37808-661-14) / 2 g in 1 TUBE2 tube2023-12-312028-01-31NoNoHistorical