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 |
|---|---|---|---|---|---|---|
| Softlips Peppermint Swirl | DIMETHICONE | The Mentholatum Company | 4dbea50e-d82d-c702-e063-6394a90ac6e4 | 2026-03-24 | Warnings | M016 |
| Softlips Vanilla | DIMETHICONE | The Mentholatum Company | 56551008-a4e0-406f-8403-980d2e6b75a0 | 2026-03-24 | Warnings | M016 |
| Selan Plus Zinc Oxide | SELAN PLUS ZINC OXIDE | Trividia Manufacturing Solutions, Inc | 07396c61-1dfd-4be7-bddf-0eb570a18463 | 2026-03-24 | Warnings | M016 |
| D-Cerin | MOISTURIZER | Dynarex Corporation | 7ea47a7e-12af-9290-e053-2a91aa0a065f | 2026-03-24 | Warnings | M016 |
| MG217 Eczema Body | COLLOIDAL OATMEAL | Wisconsin Pharmacal Company | 5f0cfd0c-ae87-f411-e053-2a91aa0ac251 | 2026-03-20 | Warnings | M016 |
| Advanced Formula Scar Defense Cream | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d5c70f9-da41-b535-e063-6294a90a73f2 | 2026-03-19 | Warnings | M016 |
| TriplePaste Adult Care Rash Treatment | ZINC OXIDE | Advantice Health, LLC | 2cf0575c-8d3d-1f16-e063-6294a90a629d | 2026-03-19 | Warnings | M016 |
| multipurpose | ZINC OXIDE SKIN PROTECTANT | Advantice Health, LLC | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2026-03-19 | Warnings | M016 |
| Triple Diaper Rash | ZINC OXIDE | Advantice Health, LLC | d457c58d-8239-41c4-999e-d0ba237e3945 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | f4464fb2-ba25-16f2-e053-2a95a90a0406 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | fea4e5c7-780c-c7f4-e053-6294a90abb39 | 2026-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d46110b-5aa7-5261-e063-6394a90a423a | 2026-03-18 | Warnings | M016 |
| Advanced Bed Sore Wound Healing | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d589c18-e597-355a-e063-6394a90a4243 | 2026-03-18 | Warnings | M016 |
| MediChoice Barrier | DIMETHICONE | O&M HALYARD, INC. | 115c2a2f-d68a-316a-e063-6394a90a2716 | 2026-03-17 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d4427b0-25c3-ddf6-e063-6394a90a6153 | 2026-03-17 | Warnings | M016 |
| Colloidal Oatmeal | COLLOIDAL OATMEAL | Walmart Inc. | 4a93f77d-41dc-3bab-e063-6394a90a804b | 2026-03-16 | Warnings, Adverse reactions | M016 |
| Vaseline | HEALING JELLY | Conopco Inc. d/b/a Unilever | bd4418b7-c6aa-5e71-e053-2995a90a4cc4 | 2026-03-16 | Warnings | M016 |
| Vaseline Intensive Care Deep Moisture | PETROLEUM | Conopco Inc. d/b/a Unilever | 65cec560-25c7-4076-a33d-a3dd534ff85b | 2026-03-16 | Warnings | M016 |
| Daily Moisturizing | DAILY MOISTRUIZING | Walgreen Co. | 27452cc7-1ec6-4571-bcd0-0a7103735ee5 | 2026-03-13 | Warnings, Adverse reactions | M016 |
| Tender Moments Delicate Baby Diaper Rash Balm | DIMETHICONE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | f09ba452-e1a6-4f45-901f-bb63d4f8e884 | 2026-03-13 | 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 |