Over-the-counter drug · OTC MONOGRAPH DRUG
Renew Intensive Skin Therapy Targeted Eczema Treatment (Colloidal oatmeal) NDC 54473-410
Oatmeal .5 g/50mL · Cream · Topical · Melaleuca Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-410-01 | 5447304100154473041001 | 50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01)Marketed from Jan 1, 2024 |
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)
- Renew Intensive Skin Therapy Targeted Eczema TreatmentSuffix: Targeted Eczema Treatment
- Generic name (nonproprietary)
- colloidal oatmeal
- Active ingredients
- Oatmeal — .5 g/50mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Melaleuca Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- 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 54473-410_42790fbf-5c8b-ad6b-e063-6294a90af297SPL ID 42790fbf-5c8b-ad6b-e063-6294a90af297SPL set ID 198c7caf-576b-1466-e063-6394a90afe25RxCUI 240651UNII 8PI54V663Y
- 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
N454473041001followed by a unit qualifier and the quantityPackage 54473-0410-01. 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 irritation and itching due to: rashes eczema
Excerpt only. Read the full label for complete information.
About NDC 54473-410
- What is NDC 54473-410?
- 54473-410 is the product NDC for Renew Intensive Skin Therapy Targeted Eczema Treatment, Oatmeal .5 g/50mL cream, listed with the FDA by Melaleuca Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Renew Intensive Skin Therapy Targeted Eczema Treatment (Colloidal Oatmeal).
- What is the active ingredient?
- Oatmeal.
- Who is the labeler?
- Melaleuca Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Renew Intensive Skin Therapy Targeted Eczema Treatment?
- 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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