XtraCare with cooling action Oatmeal Skin Relief Calmin
- Product NDC
- 57337-038
- 11-digit product format
- 573370038
- Labeler code
- 57337
- Product ID
- 57337-038_2dc099cd-a08d-d907-e063-6394a90a2929
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Rejoice International
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-11-26
- Substance
- DIMETHICONE
- Active strength
- 5 mg/354mg
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- XtraCare with cooling action Oatmeal Skin Relief Calmin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 5 mg/354mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 891710 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f99606f6-83bc-436e-aa21-53e77eb87b9c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-038-01 | XtraCare with cooling action Oatmeal Skin Relief Calmin | 354 mg in 1 BOTTLE | LOTION | 354 | 7 | |
| 57337-038-02 | XtraCare with cooling action Oatmeal Skin Relief Calmin | 227 mg in 1 BOTTLE | LOTION | 227 | 7 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| AOAO Retinol Anti-aging Box Set | COLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL. | Guangdong Junhui Biotechnology Co., LTD | 24fdc31b-5291-a649-e063-6394a90a9c65 | 2025-01-08 | Warnings | M016 |
| Sulfur anti-mite shower gel | SODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR. | Guangdong Junhui Biotechnology Co., Ltd | 251ee057-1adf-bc97-e063-6394a90acdd3 | 2025-01-08 | Warnings | M016 |
| TURMERICFaceCream | NIACINAMIDE | Shengnan (Guangzhou) Cosmetics Co., LTD | 2b0652be-a216-d66b-e063-6394a90a0b28 | 2025-01-06 | Warnings | M016 |
| Menthol and Zinc Oxide | MENTHOL AND ZINC OXIDE | GERI-GENTLE CORPORATION | e673d8bd-2573-9f04-e053-2995a90a172a | 2025-01-06 | Warnings | M016 |
| ClearSoothingCream | HYALURONIC ACID | Shengnan (Guangzhou) Cosmetics Co., LTD | 2ac88f9a-a41b-1978-e063-6394a90a2421 | 2025-01-03 | Warnings | M016 |
| MILKBODyLotion | UREA | Shengnan (Guangzhou) Cosmetics Co., LTD | 2ac99028-a811-9332-e063-6294a90aee5c | 2025-01-03 | Warnings | M016 |
| Royal Jelly Scar Balm | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | 27be84c1-0227-41ca-beb6-3855eff77e41 | 2025-01-02 | Warnings | M016 |
| Vitamin A and D | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1ea9640-4a6d-1c76-e053-2a95a90ad3b1 | 2024-12-31 | Warnings | M016 |
| Badger Diaper | ZINC OXIDE | W.S. Badger Company, Inc. | 674542b2-33fb-4664-857d-4ff1d7f768a0 | 2024-12-31 | Warnings | M016 |
| A and D Diaper Rash and Skin Protectant | LANOLIN AND PETROLATUM | Natureplex LLC | fcaf27c9-3634-4fb7-a311-2e093f055278 | 2024-12-31 | Warnings | M016 |
| ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR | LIP PROTECTANT | REVLON CONSUMER PRODUCTS CORP | f3a6fe29-7af7-bfb1-e053-2a95a90a0101 | 2024-12-30 | Warnings | M016 |
| SkinCeuticals Advanced Scar Control Skin Protectant | ALLANTOIN | L'Oreal USA Products Inc | 83f4bfbb-47d8-4fe9-ba33-85142ec6221c | 2024-12-28 | Warnings | M016 |
| Personal Cleansing with Dimethicone | DIMETHICONE | Cardinal Health 200, Inc | 3f9a1a90-ab12-4911-b8c2-df200b0dde5b | 2024-12-27 | Warnings | M016 |
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE | ZINC OXIDE | Bentley Laboratories, LLC | a35ae585-f899-4c7e-8cd2-c0b2fe6a2078 | 2024-12-27 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891710 | dimethicone 1.3 % Topical Lotion | PSN | f99606f6-83bc-436e-aa21-53e77eb87b9c | 7 |
| 891710 | dimethicone 13 MG/ML Topical Lotion | SCD | f99606f6-83bc-436e-aa21-53e77eb87b9c | 7 |
| 891710 | dimethicone 1.3 % Topical Lotion | SY | f99606f6-83bc-436e-aa21-53e77eb87b9c | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57337-038-01 | 57337003801 | 354 mg in 1 BOTTLE (57337-038-01) | 354 mg | 2013-11-26 | 0000-00-00 | No | No | Current |
| 57337-038-02 | 57337003802 | 227 mg in 1 BOTTLE (57337-038-02) | 227 mg | 2013-11-26 | 0000-00-00 | No | No | Current |