Church & Dwight Co., Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Church & Dwight Co., Inc.” (first 2006, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 128 days. Since 2017 the median was 90 days, against 144 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 172 |
| 2013 | 4 | 262 |
| 2014 | 1 | 90 |
| 2015 | 1 | 109 |
| 2016 | 3 | 84 |
| 2017 | 1 | 60 |
| 2018 | 2 | 94 |
| 2019 | 0 | — |
| 2020 | 1 | 223 |
| 2021 | 1 | 164 |
| 2022 | 2 | 74 |
| 2023 | 0 | — |
| 2024 | 1 | 244 |
| 2025 | 1 | 88 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Church & Dwight Co., Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 12 | 12 |
| NUC | Lubricant, Personal | 8 | 8 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 | 4 |
| MOL | Condom, Synthetic | 4 | 4 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 1 | 1 |
Review panels
Most recent Church & Dwight Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | HIS | 2025-02-21 | 88 |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | MOL | 2024-10-08 | 244 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | HIS | 2022-09-28 | 90 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | HIS | 2022-07-14 | 58 |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | NUC | 2021-06-11 | 164 |
| K193450 | Pre-Seed Fertility Lubricant | PEB | 2020-07-23 | 223 |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | NUC | 2018-08-01 | 131 |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | HIS | 2018-03-14 | 57 |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | MOL | 2017-08-01 | 60 |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | HIS | 2016-09-09 | 59 |
19 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2023-01-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Church & Dwight Co., Inc. is the lead sponsor of 15 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06292611: Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush (Completed, started 2023-11-27)
- NCT06126445: Single Brushing Plaque Removal Efficacy of a Battery-powered Toothbrush and a Manual Toothbrush (Completed, started 2023-11-13)
- NCT06110117: Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose (Completed, started 2023-10-27)
- NCT05506709: Sterimar Allergic Rhinitis (Completed, started 2022-07-13)
- NCT05370196: Synthetic Male Condom Slippage-Breakage Study (Completed, started 2022-06-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Church & Dwight Virginia Co., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Church & Dwight Co., Inc.?
FDA lists 29 510(k) clearances under the applicant name “Church & Dwight Co., Inc.” (first 2006, latest 2025), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Church & Dwight Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Church & Dwight Co., Inc. is 128 days. Since 2017: 90 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Church & Dwight Co., Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 12); NUC (Lubricant, Personal, 8); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 4).
Next steps
- See all 29 Church & Dwight Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Church & Dwight Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.