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 |
|---|---|---|---|---|---|---|
| TATWAX VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | 333fdce4-5a1d-45a4-94fe-81d47ecd2670 | 2025-11-07 | Warnings | M016 |
| Arme Scar Gel | DIMETHICONE | Nanjing Ludejin Corporation Management Co., Ltd | 42e9a59a-480e-f74a-e063-6294a90a0640 | 2025-11-06 | Warnings | M016 |
| Baby Diaper Rash Cream | ZINC OXIDE | Hello Bello | 42f14aa6-5694-7727-e063-6294a90a09f3 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Classic Essence | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1e874ac0-a993-be9e-e063-6394a90af424 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Eye Cream | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eeb9c36-5bd8-ec90-e063-6294a90ae4e1 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Serum | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eb08f86-eb2a-7f29-e063-6294a90a0516 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Moisturizing Cream | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eec4cfe-d5a3-3570-e063-6294a90ac38b | 2025-11-06 | Warnings | M016 |
| Spa Dry Heel Foot Relief | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9 | 2025-11-05 | Warnings | M016 |
| Royal Jelly Berry Powerful Lip Care | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | 09323fbe-76b5-48c6-80a7-c35b64110a7d | 2025-11-05 | Warnings | M016 |
| Pink Eczema Cream | COLLOIDAL OATMEAL | MOOGOO SKIN CARE PTY LTD | 3b8d92d0-ab7f-8dd5-e063-6394a90aa3af | 2025-11-04 | Warnings | M016 |
| Medline | ZINC OXIDE, PETROLATUM | Medline Industries, LP | f162b1a8-65b3-13a8-e053-2a95a90a3f13 | 2025-11-04 | Warnings | M016 |
| Medline | PETROLATUM | Medline Industries, LP | f3062b61-e4c4-9f57-e053-2995a90aa028 | 2025-11-04 | Warnings | M016 |
| Sandra Plasencia Dendrobium Officinale Soothing Biofermented Mask | TITANIUM DIOXIDE | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 3cdf06f2-63f2-7a59-e063-6294a90a72ea | 2025-11-03 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Premier Brands of America Inc. | 38583c02-497b-922c-e063-6294a90a49de | 2025-11-03 | Warnings | M016 |
| The Zoeun Omega Serum | COLLOIDAL OATMEAL | Sturgeonbio Co.,Ltd. | 4277da80-b55b-74af-e063-6394a90af325 | 2025-10-31 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Meijer Distribution Inc | 03f23b04-e7f7-49b7-e063-6294a90ad58a | 2025-10-31 | Warnings | M016 |
| Diaper Rash skin protectant | LANOLIN AND PETROLATUM | Universal Distribution Centre LLC | 1852246a-6a1c-49ab-e063-6294a90a9048 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b531c1-9ab0-5ff1-e063-6394a90a2975 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b650bd-18fe-8696-e063-6394a90aa9a2 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b5f354-3379-3d9f-e063-6294a90ae817 | 2025-10-30 | 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 |