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 |
|---|---|---|---|---|---|---|
| Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fc9eecd-fd25-827c-e063-6394a90a26a5 | 2025-03-26 | Warnings | M016 |
| Cocoa Butter Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fcc9626-6058-e9b3-e063-6394a90ab525 | 2025-03-26 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 313b08e2-d764-96da-e063-6294a90ab705 | 2025-03-25 | Warnings | M016 |
| Eczema Cream | ECZEMA CREAM | Kyte Baby LLC | 30c943aa-d9dc-5c16-e063-6294a90a3c58 | 2025-03-20 | Warnings | M016 |
| Koala Kubs Diaper Rash Cream | DIAPER RASH CREAM | Melaleuca, Inc. | c6b3b0dd-22a8-16f7-e053-2a95a90a51ea | 2025-03-20 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Skin Protectant Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 2b6b8342-878d-4588-8b24-6746d35d319d | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b20bd5-3b4f-8cc7-e063-6394a90a9106 | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b2744d-fb59-f383-e063-6294a90abd2a | 2025-03-19 | Warnings | M016 |
| Dr. Butler Hemorrhoid and Perineal | MINERAL OIL 59.8%,PETROLATUM 36% | Beyond Health P.A. | d17b6f16-6893-ce0a-e053-2a95a90aa23a | 2025-03-19 | Warnings | M016 |
| Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream | DIMETHICONE, WHITE PETROLATUM | Chattem, Inc. | b951d1cb-b81e-4d7f-9a67-8405daa89667 | 2025-03-19 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Hand Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 27457bc5-3edc-4c8b-b8a2-eaf09b511cf8 | 2025-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 30a977c3-6862-670e-e063-6294a90aeb2f | 2025-03-18 | Warnings | M016 |
| YVTYVT Copper Peptides Face Serum | COPPER TRIPEPTIDE-1 | Beijing JUNGE Technology Co., Ltd. | 306f2d48-43b8-359a-e063-6394a90a06dc | 2025-03-16 | Boxed warning, Warnings | M016 |
| Dr Talbots Cooling Perineal Pad | WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE | Talbot's Pharmaceuticals family Products, LLC. | 242277e2-ff26-ad4e-e063-6394a90ab317 | 2025-03-14 | Warnings | M016 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | M016 |
| Aavini Double Layer Brightening Spot Correcting Essence Oil | AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL | Qingyuan Moksha Biotechnology Co., Ltd. | 2ff89a13-3969-2df1-e063-6394a90ac0d3 | 2025-03-10 | Warnings | M016 |
| 5% Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3008bbeb-abba-5cdb-e063-6294a90ae483 | 2025-03-10 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2fc4745c-fac9-7861-e063-6294a90a3f14 | 2025-03-07 | Warnings | M016 |
| AD Skin Protectant | AD SKIN PROTECTANT | WellSpring Pharmaceutical Corporation | d26f1312-2e1b-4106-bc48-a336d4e034ad | 2025-03-07 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Nighttime Balm | OATMEAL | Kenvue Brands LLC | 04d90e45-c2ee-4122-b919-a0eb6d11b59a | 2025-03-04 | 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 |