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 |
|---|---|---|---|---|---|---|
| Herpecin Pain Relief | ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL | Focus Consumer Healthcare, LLC | beeb6043-6547-4fe9-e053-2995a90a5d74 | 2026-04-30 | Warnings | M016 |
| CVS | PETROLATUM | Apollo Health and Beauty Care | 47d2b9be-91ad-e9e2-e063-6294a90ac29f | 2026-04-30 | Warnings | M016 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 0578fbcb-875a-4606-acde-dcecb29756e6 | 2026-04-30 | Warnings | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Amazon.com Services LLC | 423c821d-92af-47f0-b9ee-8b68ecbcc44e | 2026-04-29 | Warnings, Adverse reactions | M016 |
| MICRO INFUSIONSYSTEM | SEEK GLO | Ningbo Kenwei International Trade Co., Ltd. | 50746cab-bfcc-fe0b-e063-6394a90adc01 | 2026-04-27 | Warnings | M016 |
| Pharmacy Choice | MENTHOL, ZINC OXIDE | PHARMACY CHOICE INC | 5031fc05-e1c7-40b1-e063-6394a90aa12c | 2026-04-24 | Warnings | M016 |
| Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION | SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY | Guangzhou Ariel Biotech Co., Ltd. | 5040b707-87af-3859-e063-6294a90afb3d | 2026-04-24 | Warnings | M016 |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | M016 |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | M016 |
| Arm and Hammer Baking Soda | SODIUM BICARBONATE | Church & Dwight Co., Inc. | 643fe204-4a7b-00e4-e053-2a91aa0aef06 | 2026-04-21 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | MY IMPORTS USA LLC | 4fba8bc7-590d-f621-e063-6294a90ad8c9 | 2026-04-18 | Warnings | M016 |
| Anti-Itch Regular Strength | HYDROCORTISONE | CVS Pharmacy | 9fe7768b-9023-c9ee-e053-2a95a90a55b3 | 2026-04-17 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Pharma Nobis, LLC | 4f853183-5925-2c73-e063-6394a90adf6c | 2026-04-15 | Warnings | M016 |
| Freskaro Calamine Plus | ZINC OXIDE LOTION | Pharma Nobis, LLC | 4f85bdc7-8fed-f1f5-e063-6394a90a6358 | 2026-04-15 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE OINTMENT | Dynarex Corporation | 11d79dd6-35f7-4399-e063-6294a90ac7dd | 2026-04-13 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f261746-37e9-7b30-e063-6294a90a9224 | 2026-04-10 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f268501-6cd7-7edd-e063-6294a90ac649 | 2026-04-10 | Warnings | M016 |
| BEVERLY HILLS MD HYDRARESCUE TREATMENT | DIMETHICONE | Beverly Hills MD, LLC | 4ed33a43-d059-2589-e063-6294a90a30b3 | 2026-04-09 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | WAL-MART STORES INC | 00faa772-53f3-9276-e063-6394a90a2dab | 2026-04-07 | Warnings | M016 |
| ProCure Zinc Oxide | ZINC OXIDE | Twin Med LLC | 37a30ee5-fd33-b410-e063-6294a90aef72 | 2026-04-07 | 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 |