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 |
|---|---|---|---|---|---|---|
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Vital Line | HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES | ANUBIS COSMETICS SL | ebe024f7-7c45-ad60-e053-2995a90a45d6 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL | ANUBIS COSMETICS SL | ebdddcec-f5da-51fe-e053-2995a90a6167 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE | ANUBIS COSMETICS SL | eb53cba1-0509-43bc-e053-2995a90a5e09 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | FERULIC ACID, VITAMIN C, DMAE | ANUBIS COSMETICS SL | eaf0770c-795d-0232-e053-2a95a90ae0b5 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Total Hydrating | BETAINE, GLYCERIN, POLYSORBATE 20 | ANUBIS COSMETICS SL | eaefe3b9-9064-18b1-e053-2a95a90a5765 | 2023-09-01 | 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 |