FDA.reportPublic FDA data

Ultra

Product NDC
55910-589
Requested package NDC
55910-589-38
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413261Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1491d2c6-8b21-4d52-ade6-aad00afa47c1Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UltraCHLOROXYLENOL 0.3%Old East Main Co.1491d2c6-8b21-4d52-ade6-aad00afa47c12026-05-08Warnings, Adverse reactionsExact identifier
ndc (package): 55910-589-38
ndc (product): 55910-589
ndc11 (package): 55910058938

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 startSampleExclude flagStatus
55910-589-38559100589381124 mL in 1 BOTTLE, DISPENSING (55910-589-38) 1124 ml2017-01-17NoNoCurrent