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 | 2026-10-23 | |
| excluded package | package | 53462-915 | 53462-915-81 | 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 | 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 |
|---|---|---|---|---|---|---|
| Rico Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a6065fcd-3968-d5a1-e053-2a95a90ab8d6 | 2025-01-20 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4465b-6e46-51e2-e063-6294a90a695f | 2025-01-16 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4a2b0-f586-3ab1-e063-6294a90aa1ed | 2025-01-16 | Warnings | M016 |
| Dermoia Manuka Honey Eczema | OATMEAL | TREASUREWISE LLC | 18c174de-6626-45ee-a6aa-f75a48daab8d | 2025-01-15 | Warnings | M016 |
| Allantoin | MEDICINAL MASSAGE OIL | Carolina Cannabis Creations L.L.C | 04b5619b-2122-f159-e063-6394a90a2e05 | 2025-01-15 | Warnings | M016 |
| Skin Barista 2in1 White Body Perfection | DIMETHICONE | Pioom Cosmetic Co.,ltd | 2d7fc20c-31a7-195b-e054-00144ff88e88 | 2025-01-15 | Warnings | M016 |
| Skin Barista Rice Bran Cleansing Foam | ALLANTOIN | Pioom Cosmetic Co.,ltd | 2d7fc7f6-1e89-116c-e054-00144ff8d46c | 2025-01-15 | Warnings | M016 |
| Hammertech Vitamin A and D | WHITE PETROLATUM | HAMMER TECH LLC | ffe96aa1-db6b-33e4-e053-6394a90a7e4e | 2025-01-14 | Warnings | M016 |
| NOON Cartessa Accelerate Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 400ead81-ab07-400f-b261-db330e0fd004 | 2025-01-14 | Warnings | M016 |
| NOON Post Procedure Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 9d1d11b4-40ff-4ea8-a3af-655f457c05f1 | 2025-01-14 | Warnings | M016 |
| OLP diaper Rash cream A and D | ZINC OXIDE | OL PHARMA TECH, LLC Drs PHARMACY | d6faa4d9-751c-a1b6-e053-2a95a90aee5b | 2025-01-09 | Warnings | M016 |
| ANTI-ITCH | ZINC ACETATE , DIPHENHYDRAMINE | OL PHARMA TECH, LLC | b79d3096-c609-e710-e053-2995a90a8da2 | 2025-01-09 | Warnings | M016 |
| ANTIBACTERIAL DREAMY FLORALS | GLYCERIN | Quimicas Handal de Centroamerica SA de CV | 09f73bec-516d-90f0-e063-6394a90aecab | 2025-01-08 | Warnings | M016 |
| AOAO Repair Foot Cream | UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL. | Guangdong Junhui Biotechnology Co.,LTD | 21064e84-c827-ca82-e063-6394a90a6c65 | 2025-01-08 | Warnings | M016 |
| A0A0 Rice Ceramide Anti Wrinkle Age Essence Box Set | BIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL. | Guangdong Junhui Biotechnology Co., LTD | 22736b2d-45a0-49b6-e063-6394a90a7b0b | 2025-01-08 | Warnings | M016 |
| Body Milk for stretch marks | HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTER | Guangzhou Senmai Biotechnology Co. | 1dcd94dc-214d-de72-e063-6294a90a695f | 2025-01-08 | Warnings | M016 |
| Stretch Marks cream | SESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8. | Guangzhou Senmai Biotechnology Co. | 1e827483-259a-d12f-e063-6394a90a7885 | 2025-01-08 | Warnings | M016 |
| Body oil for stretch marks | HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0IL | Guangzhou Senmai Biotechnology Co. | 1daeb2e8-f18c-06c3-e063-6294a90a6385 | 2025-01-08 | Warnings | M016 |
| AOA0 Snail Ginseng Cream | SNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID. | Guangdong Junhui Biotechnology Co., LTD | 22873a99-1032-f4ec-e063-6394a90a6432 | 2025-01-08 | Warnings | M016 |
| Massage cream for stretch marks | HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL | Guangzhou Senmai Biotechnology Co. | 1dce7cf1-1fb8-e14e-e063-6394a90ae34a | 2025-01-08 | 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 |