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 |
|---|---|---|---|---|---|---|
| terrasil Diabetics Ulcer and Sore Relief | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | fd6bf169-f1e2-48d4-b98d-8f3c39981a89 | 2025-05-23 | Warnings | M016 |
| Perfect 10 Soothing Recovery | PETROLATUM | Topiderm, Inc. | e3a4f038-d084-4d77-bd35-13f41856a615 | 2025-04-30 | Warnings | M016 |
| Diabetic Advanced Healing Cream | DIMETHICONE | Neoteric Cosmetics, Inc. | 46996845-9398-41d8-bf99-79f6a29bec28 | 2025-04-30 | Warnings | M016 |
| BabyDiaperCream | BABY DIAPER CREAM | Whole Foods Market | d7b19529-d0b2-638b-e053-2a95a90acf2f | 2025-04-29 | Warnings | M016 |
| ChapIce Moisture SPF 15 Lip Balm | OXYBENZONE, OCTINOXATE, PETROLATUM | Navajo Manufacturing Company Inc. | 60ce1a8c-180a-161e-e053-2991aa0ae981 | 2025-04-29 | Warnings | M016 |
| Assurance Barrier Cream | DIMETHICONE CREAM | Walmart Inc | 23a2a04f-71ce-4fa1-e063-6394a90a649e | 2025-04-22 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Moisturizing | OATMEAL | Kenvue Brands LLC | 21d2c0a0-70c3-7fd3-e063-6394a90a46d4 | 2025-04-18 | Warnings | M016 |
| Secura Extra Protective | ZINC OXIDE | Smith & Nephew Medical Ltd | 499a1944-1682-4798-9058-3748a5eaa420 | 2025-04-17 | Warnings | M016 |
| Firming Care Gel | FIRMING CARE GEL | Guangzhou Jiaan Cosmetics Co.,Ltd. | 32cb8a71-81cd-cdbd-e063-6394a90ac07f | 2025-04-15 | Warnings | M016 |
| Baby Mantra Diaper Cream | ZINC OXIDE 10% | Renu Laboratories, LLC | 0427bbc9-f4c0-0eb6-e063-6294a90a7199 | 2025-04-14 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | TOP CARE (Topco Associates LLC) | 23b592f7-3af3-45ef-897a-fe33ab518b6d | 2025-04-14 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | ef3408db-de98-4a43-9215-f80fed14815c | 2025-04-14 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Walgreens | 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 | 2025-04-11 | Warnings | M016 |
| 4% 10gTATTOO Numb Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 322daa32-a74e-1fee-e063-6294a90a37aa | 2025-04-07 | Warnings | M016 |
| Aluroderm Scar | ALLANTOIN | Asclemed USA, Inc. | 60656ca1-5218-4595-854e-19f1061def1e | 2025-04-01 | Warnings | M016 |
| Dr. Maxs Diaper | ZINC OXIDE | Dr. Maxs LLC | 31bfa962-5e3b-c5d2-e063-6294a90ac177 | 2025-04-01 | Warnings | M016 |
| Vaseline | BABY HEALING JELLY | Conopco Inc. d/b/a Unilever | bca3176f-86fe-5969-e053-2995a90a2419 | 2025-03-31 | Warnings | M016 |
| 4% TATTOO Numb Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 31646815-f591-c560-e063-6294a90ad11a | 2025-03-28 | Warnings | M016 |
| Face Saver Gel | SKIN PROTECTANT GEL | Neat Feat Products Limited | 31563dd7-9f58-80f6-e063-6294a90a5571 | 2025-03-27 | Warnings | M016 |
| Porphose | COLLOIDAL OATMEAL TOPICAL SPRAY | Porphose | 315951e0-899f-c968-e063-6294a90abe61 | 2025-03-27 | 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 |