FDA.reportPublic FDA data

Dawn Ultra Antibacterial Hand

Product NDC
37000-617
Requested package NDC
37000-617-91
11-digit product format
370000617
Labeler code
37000
Product ID
37000-617_4e66f27a-c14a-2596-e063-6394a90a7853
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOAP
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-07
Marketing end
2027-05-01
Substance
CHLOROXYLENOL
Active strength
.3 g/100mL
NDC exclude flag
No
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
Dawn Ultra Antibacterial Hand
Brand name suffix
Orange Scent

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b440e526-83c2-45b7-9c45-f95151216000Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-617-10Dawn Ultra Antibacterial HandOrange Scent1010 mL in 1 BOTTLE, PLASTICSOAP101016
37000-617-11Dawn Ultra Antibacterial HandOrange Scent1120 mL in 1 BOTTLE, PLASTICSOAP112016
37000-617-12Dawn Ultra Antibacterial HandOrange Scent1210 mL in 1 BOTTLE, PLASTICSOAP121016
37000-617-16Dawn Ultra Antibacterial HandOrange Scent1660 mL in 1 BOTTLE, PLASTICSOAP166016
37000-617-19Dawn Ultra Antibacterial HandOrange Scent192 mL in 1 BOTTLE, PLASTICSOAP19216
37000-617-20Dawn Ultra Antibacterial HandOrange Scent207 mL in 1 BOTTLE, PLASTICSOAP20716
37000-617-21Dawn Ultra Antibacterial HandOrange Scent221 mL in 1 BOTTLE, PLASTICSOAP22116
37000-617-22Dawn Ultra Antibacterial HandOrange Scent2210 mL in 1 BOTTLE, PLASTICSOAP221016
37000-617-23Dawn Ultra Antibacterial HandOrange Scent236 mL in 1 BOTTLE, PLASTICSOAP23616
37000-617-26Dawn Ultra Antibacterial HandOrange Scent266 mL in 1 BOTTLE, PLASTICSOAP26616
37000-617-38Dawn Ultra Antibacterial HandOrange Scent1120 mL in 1 BOTTLE, PLASTICSOAP112016
37000-617-40Dawn Ultra Antibacterial HandOrange Scent1200 mL in 1 BOTTLE, PLASTICSOAP120016
37000-617-47Dawn Ultra Antibacterial HandOrange Scent479 mL in 1 BOTTLE, PLASTICSOAP47916
37000-617-53Dawn Ultra Antibacterial HandOrange Scent532 mL in 1 BOTTLE, PLASTICSOAP53216
37000-617-54Dawn Ultra Antibacterial HandOrange Scent532 mL in 1 BOTTLE, PLASTICSOAP53216
37000-617-57Dawn Ultra Antibacterial HandOrange Scent573 mL in 1 BOTTLE, PLASTICSOAP57316
37000-617-59Dawn Ultra Antibacterial HandOrange Scent591 mL in 1 BOTTLE, PLASTICSOAP59116
37000-617-63Dawn Ultra Antibacterial HandOrange Scent638 mL in 1 BOTTLE, PLASTICSOAP63816
37000-617-65Dawn Ultra Antibacterial HandOrange Scent650 mL in 1 BOTTLE, PLASTICSOAP65016
37000-617-70Dawn Ultra Antibacterial HandOrange Scent709 mL in 1 BOTTLE, PLASTICSOAP70916
37000-617-82Dawn Ultra Antibacterial HandOrange Scent828 mL in 1 BOTTLE, PLASTICSOAP82816
37000-617-91Dawn Ultra Antibacterial HandOrange Scent910 mL in 1 BOTTLE, PLASTICSOAP91016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
ChloroxylenolACTIVE MOIETY0F32U78V2QDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
d&c red no. 33INACTIVE INGREDIENT9DBA0SBB0LDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
fd&c yellow no. 5INACTIVE INGREDIENTI753WB2F1MDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
lauramine oxideINACTIVE INGREDIENT4F6FC4MI8WDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFADAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
PEG-8 propylheptyl etherINACTIVE INGREDIENTHT01YH1HT1DAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
PPG-26INACTIVE INGREDIENTV86KZL3H2ZDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0DAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RDAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-617DAWN ULTRA ANTIBACTERIAL HAND ORANGE SCENT (CHLOROXYLENOL) SOAP [THE PROCTER & GAMBLE MANUFACTURING COMPANY]13Current NDC, Legacy NDC, 22 package rows20240911_b440e526-83c2-45b7-9c45-f95151216000.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
Dawn Ultra Antibacterial Hand Orange ScentCHLOROXYLENOLThe Procter & Gamble Manufacturing Companyb440e526-83c2-45b7-9c45-f951512160002026-04-01WarningsExact identifier
ndc (package): 37000-617-91
ndc (product): 37000-617
ndc11 (package): 37000061791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-617-9137000061791910 mL in 1 BOTTLE, PLASTIC (37000-617-91) 910 ml2025-02-012027-05-01NoNoHistorical