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 |
|---|---|---|---|---|---|---|
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 1ac59efd-9efd-09d9-e063-6394a90a5e40 | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a3424b96-74b0-21c4-e053-2a95a90ae7ea | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a4eb1cad-a9c0-43d3-e053-2995a90a06a0 | 2025-01-20 | Warnings | M016 |
| RICO Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | dc8ba3a2-9748-ec52-e053-2995a90a638b | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a4fa65f9-9786-76dd-e053-2995a90a6e13 | 2025-01-20 | Warnings | M016 |
| SAN Skinlab Cloth Wet Wipes | BENZALKONIUM CHLORIDE 0.13% | HANUL CO.,LTD | c058d278-3d6d-7e3c-e053-2995a90a6c2f | 2025-01-20 | Warnings | M016 |
| Rico Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a6065fcd-3968-d5a1-e053-2a95a90ab8d6 | 2025-01-20 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4465b-6e46-51e2-e063-6294a90a695f | 2025-01-16 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4a2b0-f586-3ab1-e063-6294a90aa1ed | 2025-01-16 | Warnings | M016 |
| Dermoia Manuka Honey Eczema | OATMEAL | TREASUREWISE LLC | 18c174de-6626-45ee-a6aa-f75a48daab8d | 2025-01-15 | Warnings | M016 |
| Allantoin | MEDICINAL MASSAGE OIL | Carolina Cannabis Creations L.L.C | 04b5619b-2122-f159-e063-6394a90a2e05 | 2025-01-15 | Warnings | M016 |
| Skin Barista 2in1 White Body Perfection | DIMETHICONE | Pioom Cosmetic Co.,ltd | 2d7fc20c-31a7-195b-e054-00144ff88e88 | 2025-01-15 | Warnings | M016 |
| Skin Barista Rice Bran Cleansing Foam | ALLANTOIN | Pioom Cosmetic Co.,ltd | 2d7fc7f6-1e89-116c-e054-00144ff8d46c | 2025-01-15 | Warnings | M016 |
| Hammertech Vitamin A and D | WHITE PETROLATUM | HAMMER TECH LLC | ffe96aa1-db6b-33e4-e053-6394a90a7e4e | 2025-01-14 | Warnings | M016 |
| NOON Cartessa Accelerate Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 400ead81-ab07-400f-b261-db330e0fd004 | 2025-01-14 | Warnings | M016 |
| NOON Post Procedure Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 9d1d11b4-40ff-4ea8-a3af-655f457c05f1 | 2025-01-14 | Warnings | M016 |
| OLP diaper Rash cream A and D | ZINC OXIDE | OL PHARMA TECH, LLC Drs PHARMACY | d6faa4d9-751c-a1b6-e053-2a95a90aee5b | 2025-01-09 | Warnings | M016 |
| ANTI-ITCH | ZINC ACETATE , DIPHENHYDRAMINE | OL PHARMA TECH, LLC | b79d3096-c609-e710-e053-2995a90a8da2 | 2025-01-09 | Warnings | M016 |
| ANTIBACTERIAL DREAMY FLORALS | GLYCERIN | Quimicas Handal de Centroamerica SA de CV | 09f73bec-516d-90f0-e063-6394a90aecab | 2025-01-08 | Warnings | M016 |
| AOAO Repair Foot Cream | UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL. | Guangdong Junhui Biotechnology Co.,LTD | 21064e84-c827-ca82-e063-6394a90a6c65 | 2025-01-08 | 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 |