PanOxyl
- Product NDC
- 0316-0228
- 11-digit product format
- 003160228
- Labeler code
- 0316
- Product ID
- 0316-0228_48342795-9bf1-4541-e063-6394a90a10be
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzoyl peroxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Crown Laboratories
- Application
- M006
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-25
- Substance
- BENZOYL PEROXIDE
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 product | product | 0316-0228 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 0316-0228 | 0316-0228-01 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0316-0228 | 0316-0228-03 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0316-0228 | 0316-0228-55 | D | Discontinued by firm | 2026-10-15 |
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 | 0316-0228-55 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0316-0228-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0316-0228-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0316-0228-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0316-0228-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0316-0228-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0316-0228-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0316-0228-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0316-0228-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0316-0228-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0316-0228-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0316-0228-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0316-0228-03 | 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 | 0316-0228-55 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0316-0228-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0316-0228-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- PanOxyl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOYL PEROXIDE | 100 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W9WZN9A0GM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 142034 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1660f219-e789-91f1-e063-6294a90a7664 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-02-13 | Panoxyl Acne Creamy Wash |
| 2023-02-13 | Panoxyl Acne Creamy Wash |
| 2023-02-13 | Panoxyl Acne Creamy Wash |
| 2023-01-30 | Panoxyl Acne Creamy Wash |
| 2023-01-30 | Panoxyl Acne Creamy Wash |
| 2023-01-30 | Panoxyl Acne Creamy Wash |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0316-0228-01 | PanOxyl | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 0316-0228-01 | PanOxyl | 28 g in 1 TUBE | CREAM | 28 | 4 | |
| 0316-0228-03 | PanOxyl | 85 g in 1 TUBE | CREAM | 85 | 4 | |
| 0316-0228-55 | PanOxyl | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 0316-0228-55 | PanOxyl | 156 g in 1 TUBE | CREAM | 156 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0316-0228-03 | GM - Gram | 0316-0228 | 66d86f14-d644-407d-9942-038916268d42 | 1 | 2026-04-20 |
| 0316-0228-55 | GM - Gram | 0316-0228 | e1aa066d-1bdf-49c8-9517-ceebf274be20 | 1 | 2019-01-24 |
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 |
|---|---|---|---|---|
| 142034 | benzoyl peroxide 10 % Medicated Liquid Soap | PSN | 1660f219-e789-91f1-e063-6294a90a7664 | 4 |
| 142034 | benzoyl peroxide 100 MG/ML Medicated Liquid Soap | SCD | 1660f219-e789-91f1-e063-6294a90a7664 | 4 |
| 142034 | benzoyl peroxide 10 % Medicated Liquid Soap | SY | 1660f219-e789-91f1-e063-6294a90a7664 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0316-0228-01 | 00316022801 | 1 TUBE in 1 CARTON (0316-0228-01) / 28 g in 1 TUBE | 1 tube | 2022-10-12 | No | No | Current | |
| 0316-0228-03 | 00316022803 | 85 g in 1 TUBE (0316-0228-03) | 85 g | 2022-11-12 | No | No | Current | |
| 0316-0228-55 | 00316022855 | 1 TUBE in 1 CARTON (0316-0228-55) / 156 g in 1 TUBE | 1 tube | 2018-12-01 | 0000-00-00 | No | No | Current |