Remedy Barrier Cream Cloths
- Product NDC
- 53329-078
- 11-digit product format
- 533290078
- Labeler code
- 53329
- Product ID
- 53329-078_5693e3a7-6102-0b96-e063-6294a90ab48f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-19
- Substance
- DIMETHICONE
- Active strength
- 3.6 g/100mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 53329-078 | 53329-078-91 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-078 | 53329-078-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-078 | 53329-078-91 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Remedy Barrier Cream Cloths
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 3.6 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1534833 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 00e0cd4a-6049-408a-ab3f-9edf97e6438a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-078-02 | Remedy Barrier Cream Cloths | 6.9 mL in 1 APPLICATOR | CLOTH | 6.9 | 11 | |
| 53329-078-02 | Remedy Barrier Cream Cloths | 3 in 1 PACKAGE | CLOTH | 3 | 11 | |
| 53329-078-76 | Remedy Barrier Cream Cloths | 8 in 1 PACKAGE | CLOTH | 8 | 11 | |
| 53329-078-76 | Remedy Barrier Cream Cloths | 17 mL in 1 APPLICATOR | CLOTH | 17 | 11 | |
| 53329-078-91 | Remedy Barrier Cream Cloths | 6.9 mL in 1 APPLICATOR | CLOTH | 6.9 | 11 | |
| 53329-078-91 | Remedy Barrier Cream Cloths | 48 in 1 PACKAGE | CLOTH | 48 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-078 | REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP] | 11 | Current NDC, Legacy NDC, 6 package rows | 20240120_00e0cd4a-6049-408a-ab3f-9edf97e6438a.zip |
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 |
|---|---|---|---|---|---|---|
| EELHOE Cuticle Pusher Pen | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 52c7f956-a2a1-ae1d-e063-6294a90ab3c2 | 2026-05-27 | Warnings | M016 |
| Dermoia Eczema Relief Colloidal Oatmeal | OATMEAL | Treasurewise LLC | 1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a | 2026-05-27 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Wal-Mart Stores, Inc. | 61e76e2a-fc46-7a64-e053-2991aa0a56a8 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Wal-Mart Stores, Inc. | 61929c97-bd6b-0d7c-e053-2991aa0aa571 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Pharma Nobis, LLC | fbcfa541-beda-06de-e053-6294a90a9298 | 2026-05-26 | Warnings | M016 |
| Humco Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Humco holding Group, Inc. | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 2026-05-26 | Warnings | M016 |
| Advanced Healing | PETROLATUM | CVS Pharamacy, Inc | 0bd3380e-2284-44a7-b2ef-68c9909627fd | 2026-05-26 | Warnings, Adverse reactions | M016 |
| CeraVe Developed with Dermatologists Healing Lip Balm | PETROLATUM | L'Oreal USA Products Inc | 21dc8842-0672-4d46-bcea-b8e3d54c48bf | 2026-05-20 | Warnings | M016 |
| AFTER CARE | DIMETHICONE | Merz North America | c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae | 2026-05-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Trifecta Pharmaceuticals USA | 63b551fc-7d16-c099-e053-2a91aa0a5f2c | 2026-05-18 | Warnings | M016 |
| ADVANCED SILICONE SCAR | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 51ffdc45-5acf-ae20-e063-6294a90a55e8 | 2026-05-17 | Warnings | M016 |
| LCFateLC Nail Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 51ea23f4-0a23-4ae1-e063-6394a90aa051 | 2026-05-16 | Warnings | M016 |
| Radlive Active Defense Nano-Silver Cream | COLLOIDAL OATMEAL | SilverCeuticals | 51e23135-008d-9db5-e063-6294a90a7d61 | 2026-05-15 | Warnings | M016 |
| Cerave Developed with Dermatologists Healing | PETROLATUM | LOreal USA Products Inc | de44ac01-ba17-4f97-ac12-9ea348013bde | 2026-05-14 | Warnings | M016 |
| Triple 3x Max Diaper Rash | ZINC OXIDE | Advantice Health, LLC | e554046b-cd0a-4a6e-8f24-2e610c697432 | 2026-05-14 | Warnings | M016 |
| Eczema Therapy | COLLOIDAL OATMEAL | SilverCeuticals | 3a26a35e-a098-0e22-e063-6294a90a96b9 | 2026-05-13 | Warnings | M016 |
| Nail- Pflaster | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 519681bc-6312-f627-e063-6394a90a2845 | 2026-05-11 | Warnings | M016 |
| Hydrating | PETROLATUM | Aldermed Inc. | 4aa6a354-e487-4b65-e063-6394a90abbf0 | 2026-05-09 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Aldermed Inc. | 4aa79292-dc91-b538-e063-6294a90ac3f0 | 2026-05-09 | Warnings | M016 |
| XIMONTH Nail Fungus Care Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 514a998d-aa2a-46b6-e063-6294a90a6c22 | 2026-05-08 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1534833 | dimethicone 3.6 % Medicated Pad | PSN | 00e0cd4a-6049-408a-ab3f-9edf97e6438a | 11 |
| 1534833 | dimethicone 36 MG/ML Medicated Pad | SCD | 00e0cd4a-6049-408a-ab3f-9edf97e6438a | 11 |
| 1534833 | dimethicone 3.6 % Wipe | SY | 00e0cd4a-6049-408a-ab3f-9edf97e6438a | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-078-02 | 53329007802 | 3 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR | 3 applicator | 2013-12-19 | 0000-00-00 | No | No | Current |
| 53329-078-76 | 53329007876 | 8 APPLICATOR in 1 PACKAGE (53329-078-76) / 17 mL in 1 APPLICATOR | 8 applicator | 2013-12-19 | 0000-00-00 | No | No | Current |
| 53329-078-91 | 53329007891 | 48 APPLICATOR in 1 PACKAGE (53329-078-91) > 6.9 mL in 1 APPLICATOR | 48 applicator | 2013-12-19 | 0000-00-00 | No | No | Current |