Over-the-counter drug · OTC MONOGRAPH FINAL
Eczema Care Moisturizing 3 oz. (Colloidal oatmeal) NDC 57337-101
Oatmeal 10 mg/mL · Lotion · Topical · Rejoice International Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57337-101-01 | 5733701010157337010101 | 85 mL in 1 TUBE (57337-101-01)Marketed from Mar 8, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eczema Care Moisturizing 3 oz.Suffix: 3 oz.
- Generic name (nonproprietary)
- colloidal oatmeal
- Active ingredients
- Oatmeal — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Rejoice International Inc.NDC labeler code 57337
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part347
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Grain Proteins (EXT)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)
- Identifiers
- Product ID 57337-101_83966e75-3cf0-410b-e053-2a91aa0a90f3SPL ID 83966e75-3cf0-410b-e053-2a91aa0a90f3SPL set ID 83967d26-159a-e95c-e053-2991aa0af53aUNII 8PI54V663YUPC 0849607065490
- Pharmacologic class
- Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457337010101followed by a unit qualifier and the quantityPackage 57337-0101-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Temporarily protects and helps relieve minor skin itching and irritation due to: Eczema Rashes
Excerpt only. Read the full label for complete information.
About NDC 57337-101
- What is NDC 57337-101?
- 57337-101 is the product NDC for Eczema Care Moisturizing 3 oz. (colloidal oatmeal), Oatmeal 10 mg/mL lotion, listed with the FDA by Rejoice International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eczema Care Moisturizing 3 oz. (Colloidal Oatmeal).
- What is the active ingredient?
- Oatmeal.
- Who is the labeler?
- Rejoice International Inc., NDC labeler code 57337. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eczema Care Moisturizing 3 oz.?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under part347
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Oatmeal Skin Relief Calming . 8ozdimethicone | Dimethicone 3 g/227g | LotionTopical | Rejoice International Inc. | 57337-100 |
| CVS Health Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | CVS Health | 69842-058 |
| TriCalm Hydrogelaluminum acetate | Aluminum acetate 2 mg/mL | GelTopical | Modular Thermal Technologies LLC Dba Life Wear Technologies | 71207-100 |
| Vitamin A and Dlanolin and petrolatum | Lanolin 15.5 g/100g; Petrolatum 53.4 g/100g | OintmentTopical | Family Dollar Services Inc | 55319-103 |
| Balmex Adult Care Rashzinc oxide | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-500 |
| MG217 Baby Eczemacolloidal oatmeal | Oatmeal .02 g/g | LotionTopical | Wisconsin Pharmacal Company | 68093-5105 |
| MG217 Eczema Facecolloidal oatmeal | Oatmeal .02 g/g | LotionTopical | Wisconsin Pharmacal Company | 68093-7245 |
| Natures Choice Vitamins A and Da and d ointment | Petrolatum 99.397 g/100g | OintmentTopical | Unipack, Inc. | 43749-230 |
| Astringentcalcium acetate monohydrate and aluminum sulfate tetradecahydrate | Calcium acetate monohydrate 952 mg/2299mg; Aluminum sulfate tetradecahydrate 1347 mg/2299mg | Powder, For solutionTopical | Granulation Technology, Inc. | 63561-0178 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0498 |
| Petrolatum | Petrolatum 30 g/100g | CreamTopical | Greenbrier International, Inc. | 33992-0499 |
| Balmex Multi-Purposepetrolatum | Petrolatum 511 mg/g | OintmentTopical | Randob Labs,Ltd. | 52412-450 |
| Balmex Diaper Rashzinc oxide | Zinc oxide .113 g/g | CreamTopical | Randob Labs,Ltd. | 52412-400 |
| Argan Air Water Bang Essencedimethicone | Dimethicone .01 g/100mL | CreamTopical | Pioom Cosmetic Co.,ltd | 70441-0004 |
| Burts Bees Baby Bee Diaper Rashzinc oxide | Zinc oxide 40 g/100g | OintmentTopical | BURT'S BEES, INC. | 26052-028 |