Medline Remedy Phytoplex Skin Repair
- Product NDC
- 53329-995
- 11-digit product format
- 533290995
- Labeler code
- 53329
- Product ID
- 53329-995_efe1a76d-ef6c-37f6-e053-2995a90a9538
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimeticone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-11-01
- Marketing end
- 0000-00-00
- Substance
- DIMETHICONE
- Active strength
- 5 g/100mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 53329-995 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53329-995 | 53329-995-04 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-995 | 53329-995-13 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-995 | 53329-995-23 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-995 | 53329-995-84 | 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 | 53329-995-23 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-995-13 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-995-84 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-995-04 | 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 | 53329-995-23 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-995-13 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-995-84 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-995-04 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-995-04 | 53329099504 | 118 mL in 1 TUBE (53329-995-04) | 118 ml | 2019-11-01 | 0000-00-00 | No | No | Current |
| 53329-995-13 | 53329099513 | 59 mL in 1 TUBE (53329-995-13) | 59 ml | 2019-11-01 | 0000-00-00 | No | No | Current |
| 53329-995-23 | 53329099523 | 946 mL in 1 TUBE (53329-995-23) | 946 ml | 2019-11-01 | 0000-00-00 | No | No | Current |
| 53329-995-84 | 53329099584 | 1000 mL in 1 BAG (53329-995-84) | 1000 ml | 2019-11-01 | 0000-00-00 | No | No | Current |