FDA.reportPublic FDA data

U By Kotex

Primary DI
10036000515869
Brand
U By Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Tampon
Device description
U BY KOTEX SUPER PREMIUM TAMPONS REGULAR ABSORBENCY 45
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEBTampon, menstrual, unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000515869PackageGS16In Commercial Distribution
00036000515862PrimaryGS10
00036000998399Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600051586910036000515869
00036000515862000360005158620360005158620036000515862
00036000998399000360009983990360009983990036000998399

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight9Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)335-6839xxx@xxx.xxx
+1(800)335-6839xx@xx.xx

Regulatory Flags#

DUNS number
829568273
Device count
45
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036000586329U by KotexTampon; Pad2026-02-18
00036000596168U by KotexTampon; Pad2026-02-18
00036000597295U by KotexTampon; Pad2026-02-18
00036000465693PoisePessary2016-09-23
00036000470628PoisePessary2017-02-15
00036000475753PoisePessary2017-10-10
00036000491371PoisePessary2018-01-19
10036000465690PoisePessary2016-09-23
10036000470595PoisePessary2017-02-15
10036000470601PoisePessary2017-02-15
10036000470618PoisePessary2017-02-15
10036000470625PoisePessary2017-02-15
10036000491378PoisePessary2018-01-19
00036000565430U By KotexTampon2024-10-31
00036000565447U By KotexTampon2024-10-31
00036000565454U By KotexTampon2024-10-31
10036000563068U By KotexKOTEX TAMPONS2024-09-06
00036000373042U by KotexPad2018-01-03
00036000424911U by KotexPad2018-01-03
00036000448269U by KotexPad2018-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10834533001411DG HealthDOLGENCORP, LLCHEB2026-03-23
10834533001442DG HealthDOLGENCORP, LLCHEB2026-03-23
00850068130863Pixie CupPixie Cup LLCHEB2026-03-19
00850068130870Pixie CupPixie Cup LLCHEB2026-03-19
00850068130887Pixie CupPixie Cup LLCHEB2026-03-19
00850068130894Pixie CupPixie Cup LLCHEB2026-03-19
00850068130900Pixie CupPixie Cup LLCHEB2026-03-19
00850068130917Pixie CupPixie Cup LLCHEB2026-03-19
00850068130924Pixie CupPixie Cup LLCHEB2026-03-19
00850068130931Pixie CupPixie Cup LLCHEB2026-03-19
00850068130948Pixie CupPixie Cup LLCHEB2026-03-19
00810152230848Public GoodsDon't Run Out, Inc.HEB2026-03-09
00036000597295U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
30810042482396CoraCoraHEB2026-01-21
20810042482405CoraCoraHEB2026-01-21
20810042482412CoraCoraHEB2026-01-21
20810042482429CoraCoraHEB2026-01-21
00628719704073Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704127Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704134Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704639Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539305Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539329Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539336Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500215Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500222Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704066Iris + ArloIris + Arlo Inc.HEB2026-01-05
00628942539299Iris + ArloIris + Arlo Inc.HEB2026-01-05
10050428273484CVS Health TamponsWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHEB2025-12-31
40073010720747TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2025-12-19