XtraCare with cooling action Oatmeal Skin Relief Calmin
- Product NDC
- 57337-055
- 11-digit product format
- 573370055
- Labeler code
- 57337
- Product ID
- 57337-055_126e086f-ebd9-cffb-e063-6294a90afdc5
- 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
- 3 g/227g
- 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 | 3 g/227g |
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 |
|---|---|
| 29abd476-c32d-49f0-b283-30f4ba570ab4 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57337-055-01 | 2024-02-28 | C162847 | 48780-1 | 1030e365-3070-111a-e063-dadaa90a10e2 | XtraCare with cooling action Oatmeal Skin Relief Calmin |
| 57337-055-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3070-111a-e063-dadaa90a10e2 | XtraCare with cooling action Oatmeal Skin Relief Calmin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-055-01 | XtraCare with cooling action Oatmeal Skin Relief Calmin | 227 g in 1 BOTTLE | LOTION | 227 | 3 |
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 |
|---|---|---|---|---|---|---|
| Petroleum Jelly, Lil Drug Store | PETROLATUM JELLY | Lil' Drug Store Products, Inc. | 5862af40-97e2-d792-e063-6394a90a0f1a | 2026-08-06 | Warnings | M016 |
| AOAO RAPID ACNE RELIEF | SALICYLIC ACID,BENZOYL PEROXIDE | Guangzhou Senmai Biotechnology Co.,Ltd. | 586df874-0f71-ed46-e063-6294a90a0a8e | 2026-08-06 | Warnings | M016 |
| Dealmed Vitamins A and D | WHITE PETROLATUM | Dealmed Medical Supplies, LLC. | d6584809-b438-4b2c-ab37-522e0dbef470 | 2026-08-05 | Warnings | M016 |
| Dealmed Vitamins A and D | PETROLATUM | Dealmed Medical Supplies, LLC. | 84afe4ae-f9e8-406f-9fbe-f413975f86eb | 2026-08-05 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Walgreens | 1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5 | 2026-08-04 | Warnings | M016 |
| Nail Treatment Repairing Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 57b8b3e5-88be-3a91-e063-6294a90a05be | 2026-08-03 | Warnings | M016 |
| PROCURE | ZINC OXIDE | TWIN MED, LLC | e68ae97e-668e-31c2-e053-2995a90ab4d3 | 2026-08-03 | Warnings | M016 |
| PROCURE VITAMIN A AND D Skin Protectant | PETROLATUM | TWIN MED, LLC | bbbca68e-1b65-49b1-a5fa-ed4da55d05e3 | 2026-08-03 | Warnings | M016 |
| procure | PETROLATUM | TWIN MED, LLC | 32520d8f-91ee-47a1-9129-bf0746791f4b | 2026-08-03 | Warnings | M016 |
| ProCure HydroShield | PETROLATUM 44.28% | Twin Med LLC | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2026-08-03 | Warnings | M016 |
| 456 Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 5830fd36-0613-1980-e063-6294a90adfb7 | 2026-08-03 | Warnings | M016 |
| Crogooe Skin Relief Cream | COLLOIDAL OATMEAL | Guangdong Outeli Biotechnology Co., Ltd. | 57f9b3e8-25d3-2b20-e063-6394a90aaea5 | 2026-08-01 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 57c3556a-aad3-3e65-e063-6394a90ab689 | 2026-07-29 | Warnings | M016 |
| DERMFREE INSECT BITE RELIEF | SODIUM BICARBONATE 5% INSECT BITE RELIEF | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5794886c-0d74-9f35-e063-6394a90a27d8 | 2026-07-27 | Warnings | M016 |
| OKeeffes Lip Repair SEAL and HEAL | PETROLATUM | The Gorilla Glue Company/O'Keeffe's Company | 55f66f54-da39-76c7-e063-6394a90aeda9 | 2026-07-27 | Warnings | M016 |
| ATTITUDE Baby Leaves Diaper cream - Unscented | ZINC OXIDE | 9055-7588 Quebec Inc. (Attitude) | 579aa481-f8ec-b263-e063-6394a90a7754 | 2026-07-27 | Warnings | M016 |
| Boo Boo Magic Diaper Rash Creamy | ZINC OXIDE | Alboo Brands LLC | 5114aff8-adde-e610-e063-6294a90a77ea | 2026-07-27 | Warnings | M016 |
| PrevaDRM Vitamin Repair | SKIN PROTECTANT | Sion Brands LLC | 579e4639-a742-1901-e063-6294a90a2d45 | 2026-07-27 | Warnings | M016 |
| Hello Bello Diaper Rash Cream | ZINC OXIDE | Topiderm, Inc. | e158ba31-e159-4624-a490-fe70baaf4a39 | 2026-07-24 | Warnings | M016 |
| Gethorey Vein Target Microneedle Patch | ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57593145-a874-15d9-e063-6294a90a77d9 | 2026-07-24 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891710 | dimethicone 1.3 % Topical Lotion | PSN | 29abd476-c32d-49f0-b283-30f4ba570ab4 | 3 |
| 891710 | dimethicone 13 MG/ML Topical Lotion | SCD | 29abd476-c32d-49f0-b283-30f4ba570ab4 | 3 |
| 891710 | dimethicone 1.3 % Topical Lotion | SY | 29abd476-c32d-49f0-b283-30f4ba570ab4 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57337-055-01 | 57337005501 | 227 g in 1 BOTTLE (57337-055-01) | 227 g | 2013-11-26 | 0000-00-00 | No | No | Current |