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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b20bd5-3b4f-8cc7-e063-6394a90a9106 | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b2744d-fb59-f383-e063-6294a90abd2a | 2025-03-19 | Warnings | M016 |
| Dr. Butler Hemorrhoid and Perineal | MINERAL OIL 59.8%,PETROLATUM 36% | Beyond Health P.A. | d17b6f16-6893-ce0a-e053-2a95a90aa23a | 2025-03-19 | Warnings | M016 |
| Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream | DIMETHICONE, WHITE PETROLATUM | Chattem, Inc. | b951d1cb-b81e-4d7f-9a67-8405daa89667 | 2025-03-19 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Hand Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 27457bc5-3edc-4c8b-b8a2-eaf09b511cf8 | 2025-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 30a977c3-6862-670e-e063-6294a90aeb2f | 2025-03-18 | Warnings | M016 |
| YVTYVT Copper Peptides Face Serum | COPPER TRIPEPTIDE-1 | Beijing JUNGE Technology Co., Ltd. | 306f2d48-43b8-359a-e063-6394a90a06dc | 2025-03-16 | Boxed warning, Warnings | M016 |
| Dr Talbots Cooling Perineal Pad | WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE | Talbot's Pharmaceuticals family Products, LLC. | 242277e2-ff26-ad4e-e063-6394a90ab317 | 2025-03-14 | Warnings | M016 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | M016 |
| Aavini Double Layer Brightening Spot Correcting Essence Oil | AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL | Qingyuan Moksha Biotechnology Co., Ltd. | 2ff89a13-3969-2df1-e063-6394a90ac0d3 | 2025-03-10 | Warnings | M016 |
| 5% Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3008bbeb-abba-5cdb-e063-6294a90ae483 | 2025-03-10 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2fc4745c-fac9-7861-e063-6294a90a3f14 | 2025-03-07 | Warnings | M016 |
| AD Skin Protectant | AD SKIN PROTECTANT | WellSpring Pharmaceutical Corporation | d26f1312-2e1b-4106-bc48-a336d4e034ad | 2025-03-07 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Nighttime Balm | OATMEAL | Kenvue Brands LLC | 04d90e45-c2ee-4122-b919-a0eb6d11b59a | 2025-03-04 | Warnings | M016 |
| 5% Signature Numb cream | 5% SIGNATURE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2f80abc0-49d8-968d-e063-6294a90a555b | 2025-03-04 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | f19b3056-063c-63ec-e053-2995a90a4614 | 2025-03-04 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2770424d-7414-66d4-e063-6394a90ad4b1 | 2025-03-04 | Warnings | M016 |
| Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 026bb3a1-3e01-1530-e063-6294a90ab1b1 | 2025-03-04 | Warnings | M016 |
| 5% Dr.care Numb cream | LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2f905d76-ef9c-c844-e063-6394a90a4dc9 | 2025-03-04 | Warnings | M016 |
| Desitin Maximum Strength Zinc Oxide Diaper Rash | ZINC OXIDE | Kenvue Brands LLC | 1590101a-c968-fca5-e063-6394a90a7ccc | 2025-02-28 | 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 |