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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| insect bite relief 01 | MENTHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 006e457d-bfcd-791a-e063-6294a90a8d66 | 2024-09-23 | Warnings | M016 |
| dabur | ZINC OXIDE | Dabur India Limited | 22cd1e7a-5448-b3f6-e063-6394a90a880d | 2024-09-23 | Warnings | M016 |
| DABUR Vitamin A and D | WHITE PETROLATUM | Dabur India Limited | 22cd44ef-4b02-604d-e063-6394a90a7a0a | 2024-09-23 | Warnings | M016 |
| DABUR ZINC OXIDE 3.8% | ZINC OXIDE | Dabur India Limited | 2290bbe2-8a88-b94e-e063-6294a90a7e38 | 2024-09-20 | Warnings | M016 |
| Aveeno Baby Daily Moisture | DIMETHICONE | Kenvue Brands LLC | b34c8e71-7fad-484c-b387-3c424f50b743 | 2024-09-19 | Warnings | M016 |
| Evereden Intensive Eczema Balm | COLLOIDAL OATMEAL | Eden Brands Inc. | 2243d4ca-5ca4-54d0-e063-6394a90a3940 | 2024-09-16 | Warnings | M016 |
| Whipped Gel | COLLOIDAL OATMEAL | OCEAN OLIVE LLC | 222b381c-665e-177d-e063-6394a90a3306 | 2024-09-15 | Warnings | M016 |
| BioBarrier Renewal Cream | ALLANTOIN | bluemercury | 1ee15f84-0561-3cd2-e063-6394a90ab68e | 2024-09-15 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Strategic Sourcing Services, LLC | 22173332-9d09-768c-e063-6394a90a94e1 | 2024-09-14 | Warnings | M016 |
| Diaper Rash Cream 5.6oz | ZINC OXIDE | China Ningbo Shangge Cosmetics Technology Corp. | 21a7c4ce-1360-931c-e063-6294a90aa66d | 2024-09-11 | Warnings | M016 |
| Healing Cream 3oz | PETROLATUM | China Ningbo Shangge Cosmetics Technology Corp. | 21bdbb13-cc64-b5d7-e063-6294a90ae3fd | 2024-09-11 | Warnings | M016 |
| Healing Cream15oz | PETROLATUM | Rejoice International Corp. | 21e4026c-d3da-e4f7-e063-6394a90aabed | 2024-09-11 | Warnings | M016 |
| Baby Balm Stick 0.65oz | PETROLATUM OINTMENT | China Ningbo Shangge Cosmetics Technology Corp. | 21c0b614-ea19-e98d-e063-6294a90ac44e | 2024-09-10 | Warnings | M016 |
| Aveeno Skin Relief Moisturizing Fragrance Free | DIMETHICONE | Kenvue Brands LLC | 65476a2a-8cd4-4477-ac27-9a06f41e4711 | 2024-09-09 | Warnings | M016 |
| Diaper Rash Cream 15oz | ZINC OXIDE | Rejoice International Corp. | 213213ab-f935-a62e-e063-6394a90af96b | 2024-09-03 | Warnings | M016 |
| Diaper Rash Cream 5.6oz | ZINC OXIDE | Rejoice International Corp. | 2133876b-eaf0-f988-e063-6394a90aae4d | 2024-09-03 | Warnings | M016 |
| Baby Balm Stick 0.65oz | PETROLATUM | Rejoice International Corp. | 20cf3bb8-4ab8-2980-e063-6294a90ad631 | 2024-08-29 | Warnings | M016 |
| SUDOCREM SKIN PROTECTANT | ZINC OXIDE | LEDA INNOVATIONS USA, INC. | 20d2cf0b-d237-fd78-e063-6394a90a8d03 | 2024-08-29 | Warnings | M016 |
| Healing Cream 3oz | PETROLATUM | Rejoice International Corp. | 20c9b964-c9af-d63a-e063-6294a90ab979 | 2024-08-28 | Warnings | M016 |
| Babyganics Soothing Itch | OATMEAL | KAS Direct, LLC | 5c2806fb-5af4-4532-b31a-be77bb23b277 | 2024-08-28 | Warnings | M016 |
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 |