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 |
|---|---|---|---|---|---|---|
| Herpecin Pain Relief | ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL | Focus Consumer Healthcare, LLC | beeb6043-6547-4fe9-e053-2995a90a5d74 | 2026-04-30 | Warnings | M016 |
| CVS | PETROLATUM | Apollo Health and Beauty Care | 47d2b9be-91ad-e9e2-e063-6294a90ac29f | 2026-04-30 | Warnings | M016 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 0578fbcb-875a-4606-acde-dcecb29756e6 | 2026-04-30 | Warnings | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Amazon.com Services LLC | 423c821d-92af-47f0-b9ee-8b68ecbcc44e | 2026-04-29 | Warnings, Adverse reactions | M016 |
| MICRO INFUSIONSYSTEM | SEEK GLO | Ningbo Kenwei International Trade Co., Ltd. | 50746cab-bfcc-fe0b-e063-6394a90adc01 | 2026-04-27 | Warnings | M016 |
| Pharmacy Choice | MENTHOL, ZINC OXIDE | PHARMACY CHOICE INC | 5031fc05-e1c7-40b1-e063-6394a90aa12c | 2026-04-24 | Warnings | M016 |
| Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION | SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY | Guangzhou Ariel Biotech Co., Ltd. | 5040b707-87af-3859-e063-6294a90afb3d | 2026-04-24 | Warnings | M016 |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | M016 |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | M016 |
| Arm and Hammer Baking Soda | SODIUM BICARBONATE | Church & Dwight Co., Inc. | 643fe204-4a7b-00e4-e053-2a91aa0aef06 | 2026-04-21 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | MY IMPORTS USA LLC | 4fba8bc7-590d-f621-e063-6294a90ad8c9 | 2026-04-18 | Warnings | M016 |
| Anti-Itch Regular Strength | HYDROCORTISONE | CVS Pharmacy | 9fe7768b-9023-c9ee-e053-2a95a90a55b3 | 2026-04-17 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Pharma Nobis, LLC | 4f853183-5925-2c73-e063-6394a90adf6c | 2026-04-15 | Warnings | M016 |
| Freskaro Calamine Plus | ZINC OXIDE LOTION | Pharma Nobis, LLC | 4f85bdc7-8fed-f1f5-e063-6394a90a6358 | 2026-04-15 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE OINTMENT | Dynarex Corporation | 11d79dd6-35f7-4399-e063-6294a90ac7dd | 2026-04-13 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f261746-37e9-7b30-e063-6294a90a9224 | 2026-04-10 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f268501-6cd7-7edd-e063-6294a90ac649 | 2026-04-10 | Warnings | M016 |
| BEVERLY HILLS MD HYDRARESCUE TREATMENT | DIMETHICONE | Beverly Hills MD, LLC | 4ed33a43-d059-2589-e063-6294a90a30b3 | 2026-04-09 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | WAL-MART STORES INC | 00faa772-53f3-9276-e063-6394a90a2dab | 2026-04-07 | Warnings | M016 |
| ProCure Zinc Oxide | ZINC OXIDE | Twin Med LLC | 37a30ee5-fd33-b410-e063-6294a90aef72 | 2026-04-07 | 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 |