Church & Dwight Co., Inc.: FDA clearances and approvals
Church & Dwight Co., Inc. has 29 FDA 510(k) clearances (first 2006, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time: 128 days. Since 2017 its median was 90 days, against 144 days for all cleared 510(k)s in the same product codes. openFDA lists 12 product recalls by a recalling firm named Church & Dwight Co., Inc.
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, Church & Dwight Co., Inc.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Church & Dwight Co., Inc. have?
Church & Dwight Co., Inc. has 29 FDA 510(k) clearances (first 2006, latest 2025), across 5 product codes in 2 review panels.
How long does FDA take to clear Church & Dwight Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Church & Dwight Co., Inc.'s cleared 510(k)s is 128 days. Since 2017: 90 days, versus 144 days for all cleared 510(k)s in the same product codes.
What devices does Church & Dwight Co., Inc. make?
Its most frequent FDA product codes are HIS (Condom, 12); NUC (Lubricant, Personal, 8); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 4).
Has Church & Dwight Co., Inc. had device recalls?
openFDA lists 12 product recalls in 3 recall events by a recalling firm whose name matches Church & Dwight Co., Inc; the most recent began 2023-01-25. Recall firm names are matched by name, so related entities filing under other names are not included.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.