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 | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Astonea Skin Protectant | ZINC OXIDE | ASTONEA LABS PRIVATE LIMITED | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 2024-06-25 | Warnings | M016 |
| Astonea Vitamin A and D | WHITE PETROLATUM | ASTONEA LABS PRIVATE LIMITED | ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf | 2024-06-25 | Warnings | M016 |
| ZOEY NATURALS DIAPER Cream | ZINC OXIDE | Absolutely Natural | 70fac4d6-8833-4799-b6b6-796f8f13f80e | 2024-06-25 | Warnings | M016 |
| Medicated Body | MENTHOL AND ZINC OXIDE | Universal Distribution Center LLC | 2a59a847-cc7a-42cf-b49a-92e7254c1629 | 2024-06-19 | Warnings | M016 |
| THERA Moisturizing Body Shield | DIMETHICONE | McKesson Medical-Surgical Inc. | 56869b64-11ee-4df6-8102-ce5818e0116e | 2024-06-18 | Warnings | M016 |
| Dimethicone | SKIN PROTECTANT | McKesson | 96886b33-44d4-5a2a-e053-2a95a90a505e | 2024-06-18 | Warnings | M016 |
| Derma E Eczema Relief | OATMEAL | derma e | 767c4a76-8ccb-4530-9b4b-a7ea1a596c7f | 2024-06-18 | Warnings | M016 |
| Insect sting relief pad 01 | SODIUM BICARBONATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 1b0f0088-6482-6de7-e063-6294a90aeeb7 | 2024-06-17 | Warnings | M016 |
| THERA Calazinc Body Shield | ZINC OXIDE | McKesson Medical-Surgical Inc. | 974b1046-83ee-4207-91d3-40982beb9c63 | 2024-06-17 | Warnings | M016 |
| Dimethicone | BODY CLEANSER | McKesson | 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8 | 2024-06-14 | Warnings | M016 |
| Dr. Mom Butt Balm | DIMETHICONE PETROLATUM | Ferndale Laboratories, Inc. | ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd | 2024-06-13 | Warnings | M016 |
| Secura Protective | PETROLATUM | Smith & Nephew Medical Ltd | 20906566-fbf2-46d9-a5d8-c7f7356d1080 | 2024-06-12 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | M016 |
| CVS Health Vitamin A and D Skin Protectant | LANOLIN AND PETROLATUM | CVS Health | fe3ccabb-9644-4091-9dca-ffd96a43ecaf | 2024-05-28 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | 186a9642-cd73-adfb-e063-6394a90a75c7 | 2024-05-14 | Warnings | M016 |
| Honest Eczema Balm | COLLOIDAL OATMEAL | The Honest Company, Inc. | 35b8bc5c-420e-4d31-9659-f36cabbd897a | 2024-05-14 | Warnings | M016 |
| Extra Strength Itch Stopping | ITCH STOPPING CREAM | Universal Distribution Centre LLC | b9a42aa3-1903-76f0-e053-2a95a90a51d1 | 2024-05-13 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Cardinal Health, 110 dba Leader | 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f | 2024-05-13 | Warnings | M016 |
| Walgreens Maximum Diaper Rash | ZINC OXIDE | Walgreens Company | 5eb2152f-6fa2-4191-878a-207416e69818 | 2024-05-07 | Warnings | M016 |
| Cetaphil Eczema Rapid Relief Cream | COLLOIDAL OATMEAL | Galderma Laboratories, L.P. | 02a405fa-8ae9-41e9-b86f-ef5fb6e3844a | 2024-05-02 | 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 |