Docosanol

Product NDC
55319-922
11-digit product format
553190922
Labeler code
55319
Product ID
55319-922_257bed83-00db-4b7e-98b7-3f7b6fc34266
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA208754
Marketing category
ANDA
Marketing start
2023-05-15
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
Docosanol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-922-07Docosanol2 g in 1 TUBECREAM25
55319-922-07Docosanol1 in 1 PACKAGECREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-922DOCOSANOL CREAM [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 2 package rows20230910_40297d6b-1096-467b-906c-701959884566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN40297d6b-1096-467b-906c-7019598845665
797534docosanol 100 MG/ML Topical CreamSCD40297d6b-1096-467b-906c-7019598845665
797534docosanol 10 % Topical CreamSY40297d6b-1096-467b-906c-7019598845665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-922-07553190922071 TUBE in 1 PACKAGE (55319-922-07) / 2 g in 1 TUBE1 tube2023-05-15NoNoCurrent