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 | 2026-10-16 | ||
| excluded package | package | 53329-140 | 53329-140-04 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 53329-140 | 53329-140-23 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Aveeno Daily Moisturizing | DIMETHICONE | Kenvue Brands LLC | 70593b0c-c41b-4294-9bfa-42003ba1e3e4 | 2024-11-05 | Warnings | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 029fbae2-06ad-4fe9-b542-834686c5cb97 | 2024-11-05 | Warnings | M016 |
| Aveeno Skin Relief Overnight | DIMETHICONE | Kenvue Brands LLC | e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c | 2024-11-05 | Warnings | M016 |
| Quality Choice Diaper Rash | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262e7eac-4b44-f224-e063-6394a90a4f59 | 2024-11-05 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262f8cab-c7b8-b07e-e063-6294a90a1289 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 926706b5-0a08-4604-b5ad-3b3ddfd7f02d | 2024-11-05 | Warnings | M016 |
| Walgreens Eczema Relief Body Skin Protectant | OATMEAL | Walgreen Company | b2eebc2f-addd-4822-b224-04bd5f450653 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 81eb3df4-5beb-45aa-82ca-e8b4b37e45f4 | 2024-11-05 | Warnings, Adverse reactions | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 567b1481-b783-45f9-af38-5630c9edf044 | 2024-11-01 | Warnings | M016 |
| ZO Skin Health Astringent Solution | ALUMINUM ACETATE | ZO Skin Health, Inc. | cb801d7e-52ad-6c16-e053-2a95a90a7a1f | 2024-10-31 | Warnings | M016 |
| ZINC OXIDE PHARMA | ZINC OXIDE | ALLIED TRADE LINK LLC | 1b580bf6-f217-5c0f-e063-6294a90a012e | 2024-10-29 | Warnings | M016 |
| Dove DermaSeries Eczema Relief Soothing Body | COLLOIDAL OATMEAL | Conopco, Inc. d/b/a/ Unilever | 59f737f6-dd3f-4b63-b13e-2345cb9a951a | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER SHEA BUTTER | Conopco Inc. d/b/a/ Unilever | a735d885-bacd-0f5c-e053-2a95a90ad14a | 2024-10-24 | Warnings | M016 |
| Baby Dove | 8H MOISTURIZATION HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b8dc481c-1ac3-2d63-e053-2a95a90a44f5 | 2024-10-24 | Warnings | M016 |
| Vaseline | CLINICAL CARE HAND SANITIZER LOTION | Conopco Inc. d/b/a/ Unilever | ba0aa323-8887-597f-e053-2995a90a2077 | 2024-10-24 | Warnings | M016 |
| Dove | NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION | Conopco Inc. d/b/a/ Unilever | d1039316-3ca8-90f8-e053-2995a90a2061 | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER LAVENDER | Conopco Inc. d/b/a/ Unilever | a736838b-b559-f066-e053-2995a90a90f5 | 2024-10-24 | Warnings | M016 |
| Diaper Rash Cream 2.5oz | ZINC OXIDE | Rejoice International Corp. | 130d94d8-ad98-d61f-e063-6294a90a76b0 | 2024-10-21 | Warnings | M016 |
| HARMON DAILY MOISTURZIER | DIMETHICONE | HARMON STORES, INC. | bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7 | 2024-10-21 | Warnings | M016 |
| Dimethicone | BODY SHIELD | McKesson | 8febb45d-a200-702c-e053-2995a90a3e62 | 2024-10-18 | Warnings | 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 |