Remedy Skin Repair
- Product NDC
- 53329-140
- 11-digit product format
- 533290140
- Labeler code
- 53329
- Product ID
- 53329-140_efcfafc0-8daf-3693-e053-2995a90a983f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- DIMETHICONE
- Active strength
- 2 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 | 53329-140 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53329-140 | 53329-140-04 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-140 | 53329-140-23 | 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | 53329-140 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53329-140 | 53329-140-23 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53329-140 | 53329-140-04 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7b19f89e-0a13-4d4e-a994-a46d39d008b9 | Product name | 1 | 20251120 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 13c3e0af-2da2-8aec-9e17-1afd680d80c2 | Product name | 8 | 20221116 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| f46c867f-cde5-4f14-a7c1-18ae3a6efd1c | Product name | 1 | 20160303 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-140-04 | Remedy Skin Repair | 118 mL in 1 TUBE | CREAM | 118 | 13 | |
| 53329-140-23 | Remedy Skin Repair | 946 mL in 1 BOTTLE, PUMP | CREAM | 946 | 13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Diaper Rash | ZINC OXIDE | Target Corporation | 8059f489-f144-4de5-9454-ac6c1af35dd2 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Coconut Milk and Shea Petroleum Jelly | WHITE PETROLATUM | Target Corporation | c78d9864-92e0-4ad8-8a9b-9752ac6784e8 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 043375b2-e636-4822-9e05-df2327d29986 | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 4113bb6e-070a-4116-a8d6-12c6b4475beb | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Valu Merchandisers Company | e5465ddd-e38c-44a4-bb9b-3edbc636576d | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 8b8decec-e921-4ff9-bb49-7e38e34724f6 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Valu Merchandisers Company | 0cccadd7-11f3-5d1f-e063-6294a90a55c4 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Valu Merchandisers Company | 7c6fa37f-79b8-4409-b7a9-3f02332f887a | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | United Natural Foods, Inc. dba UNFI | 014d0028-486e-4f1c-a14f-8162e393ebca | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | 29a3a719-5e8b-407d-b9d9-bdba26758292 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Topco Associates LLC | 8acb1b47-70ed-4aa2-a7c0-e807042affc7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Topco Associates LLC | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Topco Associates LLC | 3babe2cf-9e6c-4f22-940f-c1fdf489f1c7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Topco Associates LLC | 8d3d1ff5-4868-495d-807c-e45aa2176f63 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Topco Associates LLC | b929b159-4af5-4a03-8e7c-676a6ba2bf55 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Topco Associates LLC | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Topco Associates LLC | cd7f1727-0b6e-4993-9820-43783994efa1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Topco Associates LLC | f37f17f7-f084-4b74-8361-178d2315a476 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Topco Associates LLC | 4f6af42c-f41e-455f-b94b-3793bf0b9a3f | 2026-02-13 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309917 | dimethicone 1.5 % Topical Cream | PSN | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
| 309917 | dimethicone 15 MG/ML Topical Cream | SCD | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
| 309917 | dimethicone 1.5 % Topical Cream | SY | ab02322c-5862-4734-810e-7fb951c8d6a5 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-140-04 | 53329014004 | 118 mL in 1 TUBE (53329-140-04) | 118 ml | 2010-03-01 | 0000-00-00 | No | No | Current |
| 53329-140-23 | 53329014023 | 946 mL in 1 BOTTLE, PUMP (53329-140-23) | 946 ml | 2017-02-08 | 0000-00-00 | No | No | Current |