Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2280705

FEI Number

2280705

Entity Name

CHURCH & DWIGHT CO., INC.

City/State/Country

PRINCETON, NJ, US

Establishment Address

469 NORTH HARRISON STREET, PRINCETON, NJ 08543, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CHURCH & DWIGHT CO., INC. (Owner Number: 2210299)

Owner / Operator Contact Address

500 Charles Ewing Blvd., --, Ewing Township, NJ 08628, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171639

PMA Number

N/A

All Registered Proprietary Names

Trojan Magnum Lubricated Trojan Enz Lubricated Trojan Ultra Thin Trojan Ultra Ribbed Trojan Original Trojan Discovery Pack Trojan Fire & Ice Condom Trojan MAGNUM with Fire & Ice Lubricant Trojan Fire & Ice Ecstasy Condom Replens 35G Tubes Trojan Pleasures Extended Lubricated Condom Trojan ULTRAFIT FREEDOM FEEL Condom Trojan ULTRAFIT SENSITIVE TIP FEEL Condom Trojan Sensitivity Ultra-Thin Armor Condom Trojan Her Pleasure Sensations Spermicidal Trojan Her Pleasure Lubricated Condom Trojan Intensified Charged Trojan Stimulations Intense Ribbed Ultrasmooth Lubricated Trojan Sensitivity Ultra-Thin Spermicidal Trojan Stimulations Ultra Ribbed Armor Condom Trojan Her Pleasure Warm Sensations Trojan Pleasures Fire & Ice Dual Action Lubricant Trojan Her Pleasure Sensations Lubricated Trojan ENZ Armor Condom Trojan Stimulations Twisted Pleasure Trojan Her Pleasure Sensations Armor Condom Trojan Ultra ENZ Comfort Trojan The Edge Changing Sensations Condom ORAJEL COLD SORE PATCH 24CT Mighty Patch Chin, 10ct Mighty Patch Mini Invisible+ Might Patch Variety Pack Mighty Patch Nose Strips, 8ct, 10ct Mighty Patch Face 5ct Mighty Patch Invisible+ 6ct, 24ct, 27ct, 39ct Mighty Patch Day + Night 36ct Mighty Patch Original & Invisible+ Bundle Might Patch Duo 12ct Might Patch Surface,10ct Mighty Patch Body 4ct Mighty Patch Mega Pack, 84ct Mighty Patch Forehead-5ct Mighty Patch Invisible+ Jumbo 72ct Mighty Patch Original 18ct, 24ct, 27ct, 30ct, 34ct, 36ct, 60ct, 75ct Trojan Arouses & Releases Lubricant Trojan Charged Condom Trojan Intensified Charged Condom Trojan MAGNUM Condom with Warm Sensation Trojan Studded BareSkin Condoms TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges SPINBRUSH POWERED TOOTHBRUSHES (ADULTS) SPINBRUSH POWERED TOOTHBRUSHES (KIDS) SPINBRUSH POWERED TOOTHBRUSHES - REPLACEMENT HEADS (ADULTS) Spinbrush SMART CLEAN CHAMPAGNE SOFT Spinbrush SMART CLEAN Replacement Heads SOFT Spinbrush SMART CLEAN MIDNIGHT BLUE SOFT Trojan Her Pleasure Warm Sensations Trojan Ultra ENZ Comfort Trojan Intensified Charged Trojan Her Pleasure Sensations Armor Condom Trojan ULTRAFIT FREEDOM FEEL Condom Trojan Her Pleasure Sensations Lubricated Trojan Simulations Ultra Ribbed Armor Condom Trojan Pleasures Fire & Ice Dual Action Lubricant Trojan Her Pleasure Sensations Spermicidal Trojan Simulations Intense Ribbed Ultrasmooth Lubricated Trojan Her Pleasure Lubricated Condom Trojan Sensitivity Ultra-Thin Armor Condom Trojan ENZ Armor Condom Trojan The Edge Changing Sensations Condom Trojan Sensitivity Ultra-Thin Spermicidal Trojan Simulations Twisted Pleasure Trojan ULTRAFIT SENSITIVE TIP FEEL Condom Isotonic, Hypertonic Nasal Mists Simply Saline Extra Strength Plus with Calming Eucalyptus H20 Sensitive Touch Personal Lubricant Magnum Personal Lubricant H20 Closer Pre-Seed First Response Early Result Pregnancy Test First Response Pregnancy Triple Check Pregnancy Test Kit First Response Pregnancy Test & Confirm Pregnancy First Response Comfort Check Pregnancy Test Kit FIRST RESPONSE Ovulation Test Kit Spinbrush ToothTunes MULTIPLE TOOTHBRUSHES Replens LLVM, Personal Lubricant - 35g Tube w/ App Trojan ENZ Latex Non-Lubricated Condoms Trojan Magnum Thin Lubricated Pre-Seed Fertility Lubricant - Paraben Free Trojan Magnum Large Size Ribbed Condom Trojan Magnum Lubricated Condom Trojan Magnum Armor Spermicidal Trojan ULTRAFIT COMFORT FEEL Condom Trojan Magnum Large Size Thin Condom Trojan Magnum Large Size Condom Replens Silky Smooth Personal Lubricant TROJAN NaturaLamb Luxury Condom TROJAN H2O Sensitive Touch Lubricant TROJAN H2O Closer Lubricant Trojan Willa Lubricant Trojan Pure Ecstasy Condom Trojan Double Ecstasy Condom TROJAN HER PLEASURE (Ribbed) ECSTASY Trojan ULTRAFIT BARE FEEL Condom Trojan Magnum Ecstasy Ultrasmooth Lubricated Trojan Her Pleasure Ecstasy Ultrasmooth Lubricant Trojan Stimulations Ultra Ribbed Ecstasy Ultrasmooth Lubricated Mighty Patch Mini Invisible+ Mighty Patch Face 5ct Mighty Patch Invisible+, 24ct, 39 Ct Might Patch Variety Pack Might Patch Surface,10ct Mighty Patch Day + Night 36ct Mighty Patch Mega Pack, 84ct Mighty Patch Forehead-5ct Might Patch Duo Mighty Patch Body 4ct Mighty Patch Nose Strips, 8ct, 10ct Mighty Patch Duo V-DAY Edition 12ct (6 MP Original + 6 MP Invisible+) Mighty Patch Original 18ct, 24ct, 27ct, 30ct, 34ct, 36ct, 60ct, 75ct Mighty Patch Chin, 10ct Mighty Patch Invisible+ Jumbo 72ct Mighty Patch Original & Invisible+ Bundle First Response Ovulation Test (OV 7 tests + PTK 1 Test) First Response Pregnancy Test & Confirm Pregnancy First Response Ovulation Test plus bonus PreSeed Applicator Trojan Magnum Large Size XL Condom Replens Applicator Trojan Pleasures Fire & Ice Condom Trojan Fire & Ice Ecstasy Condom Trojan Fire & Ice Condom Trojan MAGNUM with Fire & Ice Lubricant Sterile Wound Wash Saline Trojan BareSkin Raw Trojan Raw - Non Latex Trojan Supra Polyurethane Bareskin Condom

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-02-04
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-12-18
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2014-10-09
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-12-01
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-12-01
LTZ	Condom With Nonoxynol-9	Obstetrics/Gynecology	Class 2	884.5310	2008-12-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-04-25
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2013-10-30
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-05-25
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2014-10-27
LFD	Saliva, Artificial	Unknown	Class U	N/A	2022-06-28
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2006-03-01
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-12-18
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2025-05-27
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2019-08-14
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2018-08-02
PEB	Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	Obstetrics/Gynecology	Class 2	884.5300	2014-10-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2014-03-04
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2004-01-26
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2004-02-12
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-10-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2016-07-25
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-02-28
PEB	Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	Obstetrics/Gynecology	Class 2	884.5300	2020-08-20
LTZ	Condom With Nonoxynol-9	Obstetrics/Gynecology	Class 2	884.5310	2008-12-01
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-12-01
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2016-05-05
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2016-07-25
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2015-04-30
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-07-11
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-05-23
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-01-31
LTZ	Condom With Nonoxynol-9	Obstetrics/Gynecology	Class 2	884.5310	2008-11-26
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-11-26
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2014-10-09
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2025-09-25
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-05-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-11-02
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2021-04-01
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2022-10-27
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2018-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHURCH & DWIGHT CO., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020300	Church & Dwight Canada Corp.	MONTREAL, QUEBEC, CA
1122329	Church & Dwight Manufacturing Co., Inc.	South Chesterfield, VA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2280705. Last updated year: 2026. Please use registration number 2280705 when referencing this establishment in official correspondence.