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 |
|---|---|---|---|---|---|---|
| Skin Mercy Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 4bac19f3-13bb-8d18-e063-6394a90aa393 | 2026-02-25 | Warnings | M016 |
| Skin Mercy Intense Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 468f21c6-2d6f-1654-e063-6394a90ab2f5 | 2026-02-25 | Warnings | M016 |
| Magnet Eye Sheet Mask | EYE MASK | Guangdong Bisutang Biotechnology Co., LTD | 4a0a84d4-4024-5ea7-e063-6394a90a2b6c | 2026-02-24 | Warnings | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Family Dollar Stores, Inc | ac7da793-8a39-4b47-b075-a4c4820cadad | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Family Dollar Stores, Inc | 1a03331e-3676-451c-be22-9a547e8ae6e2 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Family Dollar Stores, Inc | 7e64a424-afdb-4eb9-b6af-7b8123f1e207 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | H E B | e6154e44-d7b2-429c-9bc7-5c064220d3fb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | H E B | f0b31d52-2903-487a-aa70-0dbdf4c4d7e7 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | ff79e42c-da3f-4aec-acf4-cc26e10a1d08 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | H E B | a8ad595a-c811-4534-82e0-9a01085b4b1e | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | H E B | ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 460802cc-c1b9-41cb-afe3-ca4078175efb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 2dd85211-0840-4d0d-8ba7-ea6184a50942 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Meijer, Inc. | 12867b23-b203-4bd7-af6d-efddeead26be | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | c7a4b7f2-4de9-470c-9f5b-0142bd935137 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Better Living Brands, LLC | 75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8 | 2026-02-23 | Warnings, Adverse reactions | M016 |
| WHITE PETROLATUM | PETROLATUM | Sion Biotext Medical Ltd | 53ca3aeb-1d5d-4964-adb5-1cfa901642da | 2026-02-23 | Warnings | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Better Living Brands, LLC | 1d491635-9605-44fa-9860-ea23e4e8b21c | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Better Living Brands, LLC | ba50f2b2-aff8-42cd-8af0-369060a901fb | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Oatmeal | DIMETHICONE | Better Living Brands, LLC | d28c5a60-0597-424f-bf7f-08dca39b22f5 | 2026-02-23 | Warnings, Adverse reactions | 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 |