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 |
|---|---|---|---|---|---|---|
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | 4a43b1a2-2156-e490-e063-6294a90a6f84 | 2026-04-07 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE 8%, ZINC OXIDE 8% | Farmacias De Similares TX LLC | 4ecd0add-11c9-cf3b-e063-6394a90adff6 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | CVS Pharmacy, Inc. | 4dc08832-e610-4e62-a6af-cadaa339e39e | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL SPRAY | CVS Pharmacy | 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | Amazon.com Services LLC | 616ef87d-1518-46aa-8e12-9a1b678d4980 | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Stabilizing Repair Serum | OATMEAL | Dermalogica, LLC. | 86b7b230-5424-46d3-8058-656f5172fc70 | 2026-04-02 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | STRATEGIC SOURCING SERVICES | 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 | 2026-04-01 | Warnings | M016 |
| Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 4e4e1797-26e6-a67b-e063-6294a90af438 | 2026-03-31 | Warnings | M016 |
| Target Advanced Scar Gel | ADVANCED SCAR GEL | Target Corporation | 86c215fe-aad4-45d1-bdb7-cde00a115c5c | 2026-03-31 | Warnings | M016 |
| Zinc oxide, Dimethicone | ZINC OXIDE, DIMETHICONE | Walmart Inc. | 4cbf9492-33cd-e6d4-e063-6294a90ab001 | 2026-03-31 | Warnings, Adverse reactions | M016 |
| Critic-Aid Clear | PETROLATUM | Coloplast Corp | a92c18f7-52b2-43e4-bae3-2bab9de22671 | 2026-03-31 | Warnings | M016 |
| 3M Cavilon Durable Barrier | DIMETHICONE | Solventum US LLC | f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 | 2026-03-31 | Warnings | M016 |
| XIMONTH Foot Sanitizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 4e38d24d-3745-c121-e063-6394a90abbb5 | 2026-03-30 | Warnings | M016 |
| Dynashield | ZINC OXIDE | Dynarex Corporation | 59fd865c-b81d-43ad-8fa0-c37ca0557769 | 2026-03-30 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant | COLLOIDAL OATMEAL | Port Jervis Laboratories, Inc | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4275956d-275a-4e31-e063-6394a90a78d3 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Cherry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 42762471-e5cd-505e-e063-6294a90afb7d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Variety Cherry-Strawberry-Spearmint | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 450e46d2-de86-e5fa-e063-6294a90ac6ff | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4512220a-9fc2-8816-e063-6394a90a9d15 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original Military | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 45136b7e-136b-0283-e063-6394a90a599a | 2026-03-30 | 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 |