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 |
|---|---|---|---|---|---|---|
| Softlips Peppermint Swirl | DIMETHICONE | The Mentholatum Company | 4dbea50e-d82d-c702-e063-6394a90ac6e4 | 2026-03-24 | Warnings | M016 |
| Softlips Vanilla | DIMETHICONE | The Mentholatum Company | 56551008-a4e0-406f-8403-980d2e6b75a0 | 2026-03-24 | Warnings | M016 |
| Selan Plus Zinc Oxide | SELAN PLUS ZINC OXIDE | Trividia Manufacturing Solutions, Inc | 07396c61-1dfd-4be7-bddf-0eb570a18463 | 2026-03-24 | Warnings | M016 |
| D-Cerin | MOISTURIZER | Dynarex Corporation | 7ea47a7e-12af-9290-e053-2a91aa0a065f | 2026-03-24 | Warnings | M016 |
| MG217 Eczema Body | COLLOIDAL OATMEAL | Wisconsin Pharmacal Company | 5f0cfd0c-ae87-f411-e053-2a91aa0ac251 | 2026-03-20 | Warnings | M016 |
| Advanced Formula Scar Defense Cream | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d5c70f9-da41-b535-e063-6294a90a73f2 | 2026-03-19 | Warnings | M016 |
| TriplePaste Adult Care Rash Treatment | ZINC OXIDE | Advantice Health, LLC | 2cf0575c-8d3d-1f16-e063-6294a90a629d | 2026-03-19 | Warnings | M016 |
| multipurpose | ZINC OXIDE SKIN PROTECTANT | Advantice Health, LLC | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2026-03-19 | Warnings | M016 |
| Triple Diaper Rash | ZINC OXIDE | Advantice Health, LLC | d457c58d-8239-41c4-999e-d0ba237e3945 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | f4464fb2-ba25-16f2-e053-2a95a90a0406 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | fea4e5c7-780c-c7f4-e053-6294a90abb39 | 2026-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d46110b-5aa7-5261-e063-6394a90a423a | 2026-03-18 | Warnings | M016 |
| Advanced Bed Sore Wound Healing | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d589c18-e597-355a-e063-6394a90a4243 | 2026-03-18 | Warnings | M016 |
| MediChoice Barrier | DIMETHICONE | O&M HALYARD, INC. | 115c2a2f-d68a-316a-e063-6394a90a2716 | 2026-03-17 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d4427b0-25c3-ddf6-e063-6394a90a6153 | 2026-03-17 | Warnings | M016 |
| Colloidal Oatmeal | COLLOIDAL OATMEAL | Walmart Inc. | 4a93f77d-41dc-3bab-e063-6394a90a804b | 2026-03-16 | Warnings, Adverse reactions | M016 |
| Vaseline | HEALING JELLY | Conopco Inc. d/b/a Unilever | bd4418b7-c6aa-5e71-e053-2995a90a4cc4 | 2026-03-16 | Warnings | M016 |
| Vaseline Intensive Care Deep Moisture | PETROLEUM | Conopco Inc. d/b/a Unilever | 65cec560-25c7-4076-a33d-a3dd534ff85b | 2026-03-16 | Warnings | M016 |
| Daily Moisturizing | DAILY MOISTRUIZING | Walgreen Co. | 27452cc7-1ec6-4571-bcd0-0a7103735ee5 | 2026-03-13 | Warnings, Adverse reactions | M016 |
| Tender Moments Delicate Baby Diaper Rash Balm | DIMETHICONE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | f09ba452-e1a6-4f45-901f-bb63d4f8e884 | 2026-03-13 | 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 |