Data / Medical devices / United States / Church & Dwight Co., Inc.
Church & Dwight Co., Inc.: FDA-registered device maker in Princeton, NJ, United States, 42 510(k) clearances
Church & Dwight Co., Inc. is registered with the FDA (registration 2280705) in Princeton, NJ, United States. It lists 15 device types. The FDA files 42 510(k) clearances under its listings, the newest dated May 4, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2280705
- Address
- 469 North Harrison Street, Princeton, NJ, United States, 08543
- Owner or operator
- CHURCH & DWIGHT CO., INC. (2210299)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 26, 2004
- Registered through
- 2027
- Brand names listed
- FIRST RESPONSE Ovulation Test Kit, First Response Comfort Check Pregnancy Test Kit, First Response Early Result Pregnancy Test, First Response Gold Digital Pregnancy Test, First Response Ovulation Test (OV 7 tests + PTK 1 Test), First Response Ovulation Test plus bonus PreSeed Applicator, First Response Pregnancy Test & Confirm Pregnancy, First Response Pregnancy Test Strips and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent | KCJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment | accessdata.fda.gov |
| Condom | HIS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Condom With Nonoxynol-9 | LTZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2026 | K252622 | Male Latex Condom HA | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| February 21, 2025 | K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| October 8, 2024 | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | MOL | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| September 28, 2022 | K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| July 14, 2022 | K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| February 25, 2022 | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | MOL | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| June 11, 2021 | K203818 | Replens Long-Lasting Vaginal Moisturizer | NUC | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| July 24, 2020 | K192669 | Extremely Thin 003, ZERO ZERO THREE | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| July 23, 2020 | K193450 | Pre-Seed Fertility Lubricant | PEB | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| August 1, 2018 | K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | NUC | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| March 16, 2018 | K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | LFD | Substantially Equivalent | Dr. Harold Katz, LLC (Dba Therabreath | accessdata.fda.gov |
| August 1, 2017 | K171639 | Trojan Supra Lubricated Polyurethane Male Condom | MOL | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| July 23, 2014 | K141256 | OKAMOTO STUDDED CONDOM | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| July 21, 2014 | K141034 | AZUL PERSONAL LUBRICANT | NUC | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| July 1, 2014 | K140379 | MEGA BIG BOY CONDOM | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| September 10, 2013 | K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| August 26, 2013 | K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | LCX | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| June 28, 2013 | K123427 | NIRVANA D PERSONAL LUBRICANT (TBD) | NUC | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| October 4, 2012 | K120706 | NIRVANA A PERSONAL LUBRICANT | NUC | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| June 19, 2012 | K120286 | TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| May 16, 2012 | K120287 | TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| May 11, 2012 | K120249 | TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT | HIS | Substantially Equivalent | Church & Dwight Virginia Co., Inc. | accessdata.fda.gov |
| March 28, 2012 | K110690 | ONE PERSONAL LUBRICANT (SILICONE) | NUC | Substantially Equivalent | One | accessdata.fda.gov |
| August 17, 2010 | K101241 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) | NUC | Substantially Equivalent | Lil Drug Store Products, Inc. | accessdata.fda.gov |
| August 17, 2010 | K101098 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 | NUC | Substantially Equivalent | Lil Drug Store Products, Inc. | accessdata.fda.gov |
| May 12, 2010 | K092586 | MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU | HIS | Substantially Equivalent | Innolatex (Thailand) Limited | accessdata.fda.gov |
| March 31, 2009 | K090259 | OKAMOTO ULTRA THIN | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| December 29, 2008 | K083355 | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 | FRO | Substantially Equivalent | Blairex Laboratories, Inc. | accessdata.fda.gov |
| October 26, 2007 | K071313 | TROJAN-ENZ BRAND | HIS | Substantially Equivalent | Church & Dwight Co., Inc. | accessdata.fda.gov |
| May 9, 2000 | K001212 | TROJAN EXTRA LARGE LATEX CONDOM | HIS | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
| April 6, 2000 | K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | HIS | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
| October 27, 1997 | K973352 | BRAND NAME *1-STEP PREGNANCY | LCX | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
| October 27, 1997 | K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | CEP | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
| May 29, 1992 | K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | LCX | Substantially Equivalent | Syntron Bioresearch, Inc. | accessdata.fda.gov |
| February 3, 1992 | K912901 | TROJAN (TM-TBD) CONDOM | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| June 19, 1990 | K901202 | TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| April 16, 1990 | K901199 | TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| April 16, 1990 | K901194 | TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| April 16, 1990 | K901192 | TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING) | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| April 16, 1990 | K901191 | TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
| January 23, 1990 | K895640 | MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT | HIS | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
| March 7, 1988 | K874383 | MENTOR PLUS (CONDOM) | HIS | Substantially Equivalent | Arcon Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 25, 2023 | 91758 | Class II | Ongoing | 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, 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 n | accessdata.fda.gov |
| June 11, 2013 | 65686 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 22, 2011 | 60853 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
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- All makers of Condom, Synthetic
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.