Church & Dwight Co., Inc.
Princeton, NJ, US
CHURCH & DWIGHT CO., INC. appears in FDA device records in Princeton, NJ. FDA records list 29 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for Church & Dwight Co., Inc. between 2006 and 2025. The busiest year on record is 2007, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 4 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) | HIS | Substantially Equivalent | |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | MOL | Substantially Equivalent | |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | HIS | Substantially Equivalent | |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | HIS | Substantially Equivalent | |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | NUC | Substantially Equivalent | |
| K193450 | Pre-Seed™ Fertility Lubricant | PEB | Substantially Equivalent | |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | NUC | Substantially Equivalent | |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | HIS | Substantially Equivalent | |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | MOL | Substantially Equivalent | |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | HIS | Substantially Equivalent | |
| K161544 | Trojan Chain Reaction Personal Lubricant | NUC | Substantially Equivalent | |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | HIS | Substantially Equivalent | |
| K150886 | Trojan Riviera Personal Lubricant | NUC | Substantially Equivalent | |
| K141034 | AZUL PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K131887 | TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT | HIS | Substantially Equivalent | |
| K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | |
| K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | LCX | Substantially Equivalent | |
| K123427 | NIRVANA D PERSONAL LUBRICANT (TBD) | NUC | Substantially Equivalent | |
| K120706 | NIRVANA A PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K120751 | NIRVANA B PERSONAL LUBRICANT | NUC | Substantially Equivalent | |
| K120286 | TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT | HIS | Substantially Equivalent | |
| K120287 | TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT | HIS | Substantially Equivalent | |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | MOL | Substantially Equivalent | |
| K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) | LCX | Substantially Equivalent | |
| K073016 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT | HIS | Substantially Equivalent | |
| K071313 | TROJAN-ENZ BRAND | HIS | Substantially Equivalent | |
| K071272 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM | HIS | Substantially Equivalent | |
| K070054 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | MOL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2280705 | 2280705 | CHURCH & DWIGHT CO., INC. | 469 NORTH HARRISON STREET, PRINCETON, NJ 08543 US | 2026 | and 5 more, listed in full below |
| 3014967081 | 3014967081 | CHURCH & DWIGHT CO., INC. | 500 Charles Ewing Blvd., Ewing Township, NJ 08628 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KCJApplicator, Ent
- NECBandage, Liquid, Skin Protectant
- HISCondom
- LTZCondom With Nonoxynol-9
- MOLCondom, Synthetic
- FRODressing, Wound, Drug
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- NUCLubricant, Personal
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- CEPRadioimmunoassay, Luteinizing Hormone
- LFDSaliva, Artificial
- EFWToothbrush, Manual
- JEQToothbrush, Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1350-2023 | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad) | Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user. | Class II | Open, Classified | |
| Z-1811-2013 | Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs | Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination. | Class II | Terminated | |
| Z-2099-2012 | Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2098-2012 | Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2097-2012 | Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2096-2012 | Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2095-2012 | Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2094-2012 | Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-2093-2012 | Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-0859-2012 | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-0858-2012 | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated | |
| Z-0857-2012 | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain