Englewood Mesh Amenity
- Product NDC
- 59448-401
- 11-digit product format
- 594480401
- Labeler code
- 59448
- Product ID
- 59448-401_c04fd24b-cdb8-49e1-94be-8aeee1392a3d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride and Sodium Monofluorophosphate
- Dosage form
- KIT
- Labeler
- ASP Global, LLc
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-06-13
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59448-401 | 59448-401-00 | D | Discontinued by firm | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 59448-401-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 59448-401-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 59448-401-00 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 59448-401-00 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 59448-401-00 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 59448-401-00 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 59448-401-00 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 59448-401-00 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 59448-401-00 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 59448-401-00 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 59448-401-00 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 59448-401-00 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 59448-401-00 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 59448-401-00 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 59448-401-00 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Englewood Mesh Amenity
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a737fe63-6285-41ee-9516-9c3030a0ab48 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59448-401-00 | 2025-12-30 | C162847 | 48780-1 | f386c649-b26f-0266-e053-dadaa90a7c1a | Englewood Mesh Amenity Kit |
| 59448-401-00 | 2023-01-30 | C162847 | 48780-1 | f386c649-b26f-0266-e053-dadaa90a7c1a | Englewood Mesh Amenity Kit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59448-002-01 | Englewood Mesh Amenity | 53 mL in 1 BOTTLE, PLASTIC | GEL | 53 mL | 0.095 mg in 100mL | 4 |
| 59448-401-00 | Englewood Mesh Amenity | 20 in 1 BOX | KIT | 20 | 4 | |
| 59448-401-00 | Englewood Mesh Amenity | 1 in 1 BAG | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2048259 | benzalkonium chloride 0.095 % Topical Gel | PSN | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 2048259 | benzalkonium chloride 0.00095 MG/MG Topical Gel | SCD | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 2048259 | benzalkonium chloride 0.095 % Topical Gel | SY | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | a737fe63-6285-41ee-9516-9c3030a0ab48 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59448-002-01 | 59448000201 | 53 mL in 1 BOTTLE, PLASTIC | 53 ml | Historical | ||||
| 59448-401-00 | 59448040100 | 20 BAG in 1 BOX (59448-401-00) > 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 53 mL in 1 BOTTLE, PLASTIC (59448-002-01) * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 10 g in 1 TUBE (42555-060-45) | 20 bag | 2018-06-13 | 0000-00-00 | No | No | Current |