Comfort Shield Barrier
- Product NDC
- 53462-915
- 11-digit product format
- 534620915
- Labeler code
- 53462
- Product ID
- 53462-915_54ee06dc-1e51-3f8a-e063-6294a90a1fb0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dimethicone
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Sage Products LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1990-01-01
- Substance
- DIMETHICONE
- Active strength
- 30 mg/g
- 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 | 53462-915 | 53462-915-62 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 53462-915 | 53462-915-81 | D | Discontinued by firm | 2026-10-21 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53462-915-81 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53462-915-62 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53462-915-62 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53462-915-62 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53462-915-62 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53462-915-62 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53462-915-62 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 53462-915-62 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 53462-915-62 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 53462-915-62 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 53462-915-62 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 53462-915-62 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 53462-915-62 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Comfort Shield Barrier
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 30 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53462-915-24 | Comfort Shield Barrier | 24 g in 1 APPLICATOR | CLOTH | 24 | 16 | |
| 53462-915-24 | Comfort Shield Barrier | 24 in 1 PACKAGE | CLOTH | 24 | 16 | |
| 53462-915-50 | Comfort Shield Barrier | 26 g in 1 APPLICATOR | CLOTH | 26 | 16 | |
| 53462-915-50 | Comfort Shield Barrier | 3 in 1 PACKAGE | CLOTH | 3 | 16 | |
| 53462-915-51 | Comfort Shield Barrier | 3 in 1 PACKAGE | CLOTH | 3 | 16 | |
| 53462-915-51 | Comfort Shield Barrier | 19 g in 1 APPLICATOR | CLOTH | 19 | 16 | |
| 53462-915-62 | Comfort Shield Barrier | 24 g in 1 APPLICATOR | CLOTH | 24 | 16 | |
| 53462-915-62 | Comfort Shield Barrier | 24 in 1 PACKAGE | CLOTH | 24 | 16 | |
| 53462-915-80 | Comfort Shield Barrier | 27 g in 1 APPLICATOR | CLOTH | 27 | 16 | |
| 53462-915-80 | Comfort Shield Barrier | 8 in 1 PACKAGE | CLOTH | 8 | 16 | |
| 53462-915-81 | Comfort Shield Barrier | 19 g in 1 APPLICATOR | CLOTH | 19 | 16 | |
| 53462-915-81 | Comfort Shield Barrier | 8 in 1 PACKAGE | CLOTH | 8 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53462-915-50 | EA - Each | 53462-915 | 86d72459-ae42-4f14-82c1-9a3562488a17 | 1 | 2012-07-24 |
| 53462-915-51 | EA - Each | 53462-915 | 8f65a50a-b111-45b6-92fc-cb0281b43583 | 1 | 2012-07-24 |
| 53462-915-60 | EA - Each | 53462-915 | 5e281b48-6ba9-471a-a477-dd3fed32e90c | 1 | 2012-07-24 |
| 53462-915-80 | EA - Each | 53462-915 | 25b8c726-486d-4f6d-bc84-a120976ca2bb | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 Skin Advanced Mole Remove Serum | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3efd75f9-438a-f811-e063-6394a90a9450 | 2025-11-27 | Warnings | M016 |
| EELHOE Wart Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3127d616-1933-e783-e063-6294a90a52f7 | 2025-11-27 | Warnings | M016 |
| EELHOE Tanning Mist | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32670243-957d-3a95-e063-6394a90a5893 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3ddd3fb0-b824-0cde-e063-6394a90aea6a | 2025-11-27 | Warnings | M016 |
| WART REMOVER | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3fd47677-52c9-6d43-e063-6294a90aa45b | 2025-11-27 | Warnings | M016 |
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1088604 | Comfort Shield 3 % Medicated Pad | PSN | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 968663 | dimethicone 3 % Medicated Pad | PSN | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 1088604 | dimethicone 30 MG/ML Medicated Pad [Comfort Shield] | SBD | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 968663 | dimethicone 30 MG/ML Medicated Pad | SCD | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 1088604 | Comfort Shield 3 % Medicated Pad | SY | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 1088604 | Comfort Shield 30 MG/ML Medicated Pad | SY | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 968663 | dimethicone 3 % Medicated Pad | SY | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
| 968663 | dimethicone 3 % Wipe | SY | cc08f571-84ae-4c2f-b09d-a83a8efc39f5 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53462-915-24 | 53462091524 | 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR | 24 applicator | 2023-12-11 | No | No | Current | |
| 53462-915-50 | 53462091550 | 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR | 3 applicator | 1990-01-01 | 0000-00-00 | No | No | Current |
| 53462-915-51 | 53462091551 | 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR | 3 applicator | 1990-01-01 | 0000-00-00 | No | No | Current |
| 53462-915-62 | 53462091562 | 24 APPLICATOR in 1 PACKAGE (53462-915-62) > 24 g in 1 APPLICATOR | 24 applicator | 1990-01-01 | 0000-00-00 | No | No | Current |
| 53462-915-80 | 53462091580 | 8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR | 8 applicator | 1990-01-01 | 0000-00-00 | No | No | Current |
| 53462-915-81 | 53462091581 | 8 APPLICATOR in 1 PACKAGE (53462-915-81) > 19 g in 1 APPLICATOR | 8 applicator | 1990-01-01 | 0000-00-00 | No | No | Current |