FDA.reportPublic FDA data

Ultra

Product NDC
55910-589
11-digit product format
559100589
Labeler code
55910
Product ID
55910-589_514e49e7-49a0-cc3d-e063-6294a90ac679
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol 0.3%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Old East Main Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-17
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0F32U78V2Q
Rxcui413261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-589-38Ultra1124 mL in 1 BOTTLE, DISPENSINGLIQUID112421
55910-589-44Ultra532 mL in 1 BOTTLE, DISPENSINGLIQUID53221
55910-589-57Ultra1183 mL in 1 BOTTLE, DISPENSINGLIQUID118321
55910-589-68Ultra1656 mL in 1 BOTTLE, DISPENSINGLIQUID165621

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-589ULTRA (CHLOROXYLENOL 0.3%) LIQUID [OLD EAST MAIN CO]18Current NDC, Legacy NDC, 4 package rows20241013_1491d2c6-8b21-4d52-ade6-aad00afa47c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN1491d2c6-8b21-4d52-ade6-aad00afa47c121
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD1491d2c6-8b21-4d52-ade6-aad00afa47c121
413261chloroxylenol 0.3 % Medicated Liquid SoapSY1491d2c6-8b21-4d52-ade6-aad00afa47c121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-589-38559100589381124 mL in 1 BOTTLE, DISPENSING (55910-589-38) 1124 ml2017-01-17NoNoCurrent
55910-589-4455910058944532 mL in 1 BOTTLE, DISPENSING (55910-589-44) 532 ml2017-01-170000-00-00NoNoCurrent
55910-589-57559100589571183 mL in 1 BOTTLE, DISPENSING (55910-589-57) 1183 ml2017-01-170000-00-00NoNoCurrent
55910-589-68559100589681656 mL in 1 BOTTLE, DISPENSING (55910-589-68) 1656 ml2017-01-170000-00-00NoNoCurrent