Docosanol

Product NDC
63941-922
11-digit product format
639410922
Labeler code
63941
Product ID
63941-922_35918a10-dd3a-44da-8d28-29a1dc408b02
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2023-09-01
Marketing end
2027-02-01
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docosanol

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
63941-922-07Docosanol2 g in 1 TUBECREAM23
63941-922-07Docosanol1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-922DOCOSANOL CREAM [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2Current NDC, 2 package rows20231107_ea458b65-8144-4671-857a-33b19c453e05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSNea458b65-8144-4671-857a-33b19c453e053
797534docosanol 100 MG/ML Topical CreamSCDea458b65-8144-4671-857a-33b19c453e053
797534docosanol 10 % Topical CreamSYea458b65-8144-4671-857a-33b19c453e053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-922-07639410922071 TUBE in 1 PACKAGE (63941-922-07) / 2 g in 1 TUBE1 tube2023-09-012027-02-01NoNoHistorical