XtraCare Oatmeal Daily Moisturizing
- Product NDC
- 57337-138
- Requested package NDC
- 57337-138-01
- 11-digit product format
- 573370138
- Labeler code
- 57337
- Product ID
- 57337-138_2e12de28-f85b-9518-e063-6394a90ae58f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Rejoice International Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-19
- Substance
- DIMETHICONE
- Active strength
- 1.3 g/100g
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 57337-138 | 57337-138-01 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 57337-138 | 57337-138-01 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 57337-138 | 57337-138-01 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
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 Oatmeal Daily Moisturizing
- Brand name suffix
- 8 oz
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 1.3 g/100g |
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 |
|---|---|
| c055d5fb-7398-26e4-e053-2995a90acd41 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57337-138-01 | 2025-02-13 | C162847 | 48780-1 | 2cef2736-7926-d83d-e063-dadaa90ab31f | XtraCare Oatmeal Daily Moisturizing Lotion 8 oz |
| 57337-138-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7926-d83d-e063-dadaa90ab31f | XtraCare Oatmeal Daily Moisturizing Lotion 8 oz |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-138-01 | XtraCare Oatmeal Daily Moisturizing8 oz | 227 g in 1 BOTTLE, PUMP | LOTION | 227 | 2 |
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 |
|---|---|---|---|---|---|---|
| ZO Skin Health Post Procedure Program | ALUMINUM ACETATE | ZO Skin Health, Inc. | 9786acc8-06ae-4f2b-9602-b7e8c3baeca5 | 2024-11-12 | Warnings | M016 |
| DUKAL WHITE PETROLATUM | PETROLATUM | Dukal LLC | 0c6474ed-2343-d5f2-e063-6394a90a30b3 | 2024-11-12 | Warnings | M016 |
| CVS Health Advanced Scar Gel | ADVANCED SCAR GEL | CVS Health | 2fead2d8-b645-4d45-8e5b-b4f1da4e5a25 | 2024-11-12 | Warnings | M016 |
| CVS Health Advanced Scar Gel | ADVANCED SCAR GEL | CVS Health | c6926594-ad4e-4937-bda2-9311219a8881 | 2024-11-12 | Warnings | M016 |
| CVS Zinc Oxide | ZINC OXIDE | CVS Health | d67533b1-ae3f-4c9a-a6c9-a742290c90e9 | 2024-11-11 | Warnings | M016 |
| CVS Eczema Relief Skin Protectant | OATMEAL | CVS Health | 3cf25c43-592f-41cb-aa0b-a82f4e7faf3d | 2024-11-11 | Warnings | M016 |
| DGH Advanced Formula Scar Skin Protectant | ALLANTOIN | Dolgencorp Inc | 950dcffd-d2c3-4ca7-8a15-7cb1016ca364 | 2024-11-08 | Warnings | M016 |
| ABC Arbonne Baby Care Diaper Rash | DIMETHICONE AND ZINC OXIDE | Arbonne International, LLC | dd1d8198-bb9d-4508-a971-ae3bc624cdd1 | 2024-11-08 | Warnings | M016 |
| SUPER SENSITIVE DIAPER RASH | ZINC OXIDE | ORGANIC & SUSTAINABLE BEAUTY | b0de2a9b-7854-4caf-b7ff-632c1d4a382e | 2024-11-08 | Warnings | M016 |
| Dove | DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION | Conopco, Inc. d/b/a/ Unilever | bcfb12ea-304e-7d8c-e053-2a95a90af606 | 2024-11-07 | Warnings | M016 |
| Vaseline | CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM | Conopco, Inc. d/b/a/ Unilever | bd206830-e334-3764-e053-2995a90a74ca | 2024-11-07 | Warnings | M016 |
| Dove | MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR | Conopco Inc. d/b/a/ Unilever | b9e61a03-e000-50ab-e053-2a95a90a3210 | 2024-11-07 | Warnings | M016 |
| Dove | DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH | Conopco Inc. d/b/a/ Unilever | b9f8cb31-560c-79e0-e053-2a95a90a39ae | 2024-11-07 | Warnings | M016 |
| Dove | CARE AND PROTECT ANTIBACTERIAL HAND WASH | Conopco Inc. d/b/a/ Unilever | ed234413-777a-9c82-e053-2a95a90a6f98 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | CATCHING THE SUNRISE HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b9fa6c72-7c56-6fd0-e053-2995a90a6707 | 2024-11-07 | Warnings | M016 |
| Dove | CARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASH | Conopco Inc. d/b/a/ Unilever | ed24b320-27fc-9714-e053-2995a90a79a6 | 2024-11-07 | Warnings | M016 |
| SKINSEI | ETHYL ALCOHOL LIQUID | Conopco Inc. d/b/a/ Unilever | a603c419-238f-0bae-e053-2a95a90abc2b | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | UNDER THE STARLIT SKY HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0dfe52-c550-94fd-e053-2995a90a9800 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SUMMERTIME SPRINKLERS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0e474c-db62-910f-e053-2995a90a889e | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | GIRLS NIGHT OUT HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ce03e-5e7b-b09a-e053-2995a90a4eef | 2024-11-07 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891710 | dimethicone 1.3 % Topical Lotion | PSN | c055d5fb-7398-26e4-e053-2995a90acd41 | 2 |
| 891710 | dimethicone 13 MG/ML Topical Lotion | SCD | c055d5fb-7398-26e4-e053-2995a90acd41 | 2 |
| 891710 | dimethicone 1.3 % Topical Lotion | SY | c055d5fb-7398-26e4-e053-2995a90acd41 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57337-138-01 | 57337013801 | 227 g in 1 BOTTLE, PUMP (57337-138-01) | 227 g | 2021-04-19 | 0000-00-00 | No | No | Current |