XtraCare with cooling action Oatmeal Skin Relief Calmin
- Product NDC
- 57337-055
- Requested package NDC
- 57337-055-01
- 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 |
|---|---|---|---|---|---|---|
| Sunmark Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 08c00c1a-7ec8-4624-9db0-a0e8430cd126 | 2023-12-19 | Warnings | M016 |
| Sunmark Caldyphen Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 329cd4ef-b699-46ff-a5d6-907f7c327c03 | 2023-12-19 | Warnings | M016 |
| DDM Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d536077-b5c6-29b8-e053-2a91aa0a9ae1 | 2023-12-19 | Warnings | M016 |
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | Warnings | M016 |
| GNP Witch Hazel | WITCH HAZEL | Amerisource Bergen | 45ac839d-215d-4c5f-8ae5-5e111d170061 | 2023-12-14 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant | GLYCERIN | L'Oreal USA Products Inc | 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 | 2023-12-11 | 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 |