Antibacterial Lotions Skin Cleanser

Product NDC
65601-841
Requested package NDC
65601-841-19
11-digit product format
656010841
Labeler code
65601
Product ID
65601-841_5b10b900-01a0-d0c7-e063-6394a90a86b3
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOAP
Route
TOPICAL
Labeler
Betco Corporation, Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-12
Substance
CHLOROXYLENOL
Active strength
4 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Lotions Skin Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL4 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
1150812Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b2d1076-2c8b-8869-e063-6394a90a1ac4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
65601-841-04Antibacterial Lotions Skin Cleanser3780 mL in 1 JUGSOAP37802
65601-841-10Antibacterial Lotions Skin Cleanser1100 mL in 1 BAGSOAP11002
65601-841-19Antibacterial Lotions Skin Cleanser900 mL in 1 BAGSOAP9002
65601-841-29Antibacterial Lotions Skin Cleanser1000 mL in 1 BAGSOAP10002
65601-841-55Antibacterial Lotions Skin Cleanser207900 mL in 1 DRUMSOAP2079002
65601-841-88Antibacterial Lotions Skin Cleanser500 mL in 1 BOTTLE, PUMPSOAP5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65601-841ANTIBACTERIAL LOTIONS SKIN CLEANSER (CHLOROXYLENOL) SOAP [BETCO CORPORATION, LTD.]1Current NDC, 6 package rows20241109_1b2d1076-2c8b-8869-e063-6394a90a1ac4.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
Antibacterial Lotions Skin CleanserCHLOROXYLENOLBetco Corporation, Ltd.1b2d1076-2c8b-8869-e063-6394a90a1ac42026-09-09WarningsExact identifier
ndc (package): 65601-841-19
ndc (product): 65601-841
ndc11 (package): 65601084119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1150812chloroxylenol 0.4 % Medicated Liquid SoapPSN1b2d1076-2c8b-8869-e063-6394a90a1ac42
1150812chloroxylenol 4 MG/ML Medicated Liquid SoapSCD1b2d1076-2c8b-8869-e063-6394a90a1ac42
1150812chloroxylenol 0.4 % Medicated Liquid SoapSY1b2d1076-2c8b-8869-e063-6394a90a1ac42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65601-841-1965601084119900 mL in 1 BAG (65601-841-19) 900 ml2016-02-01NoNoCurrent