Remedy Barrier Cream Cloths
- Product NDC
- 53329-078
- Requested package NDC
- 53329-078-91
- 11-digit product format
- 533290078
- Labeler code
- 53329
- Product ID
- 53329-078_5dfae20d-0a48-f832-e063-6394a90a0aff
- 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 | 2026-10-23 |
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 |
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 |
|---|---|---|---|---|---|---|
| CUREFINI | PETROLATUM, COD LIVER OIL | Miramar Cosmetics, Inc DBA Miramar Lab | fc9211db-71aa-44d8-a00b-65f1482d3981 | 2024-12-23 | Warnings | M016 |
| CUREFINI | PETROLATUM | Miramar Cosmetics, Inc DBA Miramar Lab | 6a2610ca-ca80-451f-8fed-b982443a10b9 | 2024-12-23 | Warnings | M016 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 453dffec-de9d-0eac-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 455a16fd-9ce5-6bef-e054-00144ff88e88 | 2024-12-20 | Warnings | M016 |
| White Petrolatum | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1eb0ec2-98e7-13a2-e053-2a95a90a2938 | 2024-12-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Pharmacy Value Alliance, LLC | 38018e3f-3778-01d1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| DiaperRashOintment | ZINC OXIDE | Pharmacy Value Alliance, LLC | 3aace6d8-d24c-00e1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| Medicated Body Powder | MENTHOL | New Pride Corp | f0f0e332-cb93-42a7-e053-2995a90ac4ae | 2024-12-19 | Warnings | M016 |
| Health Smart Medicated Body | MENTHOL AND ZINC OXIDE | International Wholesale Inc dba Home Smart Products | 044870e2-ebac-a095-e063-6294a90a2751 | 2024-12-19 | Warnings | M016 |
| White Rain Original Petroleum | WHITE PETROLEUM | INTERNATIONAL WHOLESALE INC. | d6ebe00c-b692-5171-e053-2a95a90a976c | 2024-12-19 | Warnings | M016 |
| Health Smart Original Petroleum | WHITE PETROLEUM | Home Smart Products | aedf746f-4c49-421d-a666-1ba02e8fb17d | 2024-12-19 | Warnings | M016 |
| white rain Cocoa Butter Petroleum Jelly | WHITE PETROLATUM | INTERNATIONAL WHOLESALE INC. | d7068e2b-c3b2-d16d-e053-2a95a90a6dd2 | 2024-12-19 | Warnings | M016 |
| Savvy Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE | Savvy Care and Cosmetics | 05ee2662-6a51-6e49-e063-6294a90a4ed7 | 2024-12-19 | Warnings | M016 |
| Health Smart Lavender Baby Petroleum | WHITE PETROLEUM | Home Smart Products | 5828df37-2a42-4129-8e4e-d5ac9c4c9615 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | 980d030a-feaf-4a81-865e-f85c66151380 | 2024-12-19 | Warnings | M016 |
| Baby Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | caf568aa-3889-41ff-835e-875bb6d9ca79 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95 | 2024-12-19 | Warnings | M016 |
| Cars Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 9905b5a4-382e-4d2a-b971-37998c14c330 | 2024-12-19 | Warnings | M016 |
| Health Smart Aloe Vera Petroleum | WHITE PETROLEUM | Home Smart Products | 2671f2ed-af9d-4234-95bf-def368242a78 | 2024-12-19 | Warnings | M016 |
| DCH Scar | ALLANTOIN 0.5% | Derma Care Research Labs, LLC | 00edbc64-9d32-5751-e063-6294a90a400b | 2024-12-19 | 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 |
|---|---|---|---|---|---|---|---|---|
| 53329-078-91 | 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 |