Over-the-counter drug · OTC MONOGRAPH DRUG
Diaper Rash Cream (Zinc oxide) NDC 83369-002
Zinc oxide 15 g/100g · Cream · Topical · Smalls Brand LLC DBA Roe Wellness
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83369-002-01 | 83369000201 | 85 g in 1 CARTON (83369-002-01)Marketed from Feb 27, 2026 |
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)
- Diaper Rash Cream
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — 15 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Smalls Brand LLC DBA Roe WellnessNDC labeler code 83369
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 83369-002_4bd29285-29b5-5d57-e063-6294a90af481SPL ID 4bd29285-29b5-5d57-e063-6294a90af481SPL set ID 4bd29285-29b4-5d57-e063-6294a90af481RxCUI 245660UNII SOI2LOH54Z
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
N483369000201followed by a unit qualifier and the quantityPackage 83369-0002-01. 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)
Stop use and ask a doctor if rash occurs
Excerpt only. Read the full label for complete information.
About NDC 83369-002
- What is NDC 83369-002?
- 83369-002 is the product NDC for Diaper Rash Cream (zinc oxide), Zinc oxide 15 g/100g cream, listed with the FDA by Smalls Brand LLC DBA Roe Wellness. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diaper Rash Cream (Zinc Oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- Smalls Brand LLC DBA Roe Wellness, NDC labeler code 83369. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diaper Rash Cream?
- 2 other product NDCs are listed under this name. See all Diaper Rash Cream NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diaper Rash Cream products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diaper Rash Creamzinc oxide | Zinc oxide 8 g/100g | CreamTopical | Foshan Desha Biotechnology Co., Ltd. | 87781-001 | 87781-0001-01 |
| Diaper Rash Creamnon nano zinc oxide | Zinc oxide 11.55 g/50mL | CreamTopical | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | 82123-022 | 82123-0022-51 |
Other NDCs under M 016
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 |
|---|---|---|---|---|
| Colloidal oatmeal | Oatmeal 10 mg/g | CreamTopical | Meijer, Inc. | 79481-6601 |
| Gold Bond Eczema Relief Medicated Hand Creamcolloidal oatmeal | Oatmeal 2 g/100g | CreamTopical | Chattem, Inc. | 41167-0668 |
| Venrockrosemary oil | Rosmarinus officinalis (Rosemary) leaf oil 55 g/100g; Biotin .001 g/100g | OilTopical | Guangzhou Oupeng Cosmetics Co., Ltd | 85772-0007 |
| First Aid Beauty FAB Ultra Repair Body Skin Protectantcolloidal oatmeal | Oatmeal .5 g/100g | LotionTopical | The Procter & Gamble Manufacturing Company | 69423-726 |
| AHHH Bite Reliefsodium bicarbonate | Sodium bicarbonate 5 g/25g | GelTopical | 78271 | 78271-041 |
| Vitacilina Bebe Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | Taisho Pharmaceutical California Inc. | 81929-002 |
| Witch Hazel | Witch hazel 842 mg/mL | LiquidTopical | TOP CARE (Topco Associates LLC) | 36800-039 |
| First Aid Beauty Face and Body Bestsellers Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-911 |
| Skin Protectant with 33% Petrolatum Advance Moisturizing Creampetrolatum | Petrolatum 33 g/100g | CreamTopical | Aldermed Inc. | 87236-011 |
| Theriac Advanced Healinglanolin | Lanolin 350.8 mg/g | OintmentTopical | Sheffield Pharmaceuticals LLC | 11527-325 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-060 |
| Sarnacolloidal oatmeal | Oatmeal 20 mg/mL | LotionTopical | Crown Laboratories, Inc. | 0316-0256 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kitcolloidal oatmeal | — | KitTopical | The Procter & Gamble Manufacturing Company | 84126-912 |
| ProCure Zinc Oxidezinc oxide | Zinc oxide 20 g/100g | OintmentTopical | Twin Med LLC | 55681-017 |
| XtraCare Creamy Petroleum Jellypetrolatum | Petrolatum 38 g/127g | JellyTopical | Rejoice International | 57337-061 |
| Zinc Oxide 20%zinc oxide | Zinc oxide .2 g/g | OintmentTopical | Trifecta Pharmaceuticals USA | 69396-021 |
| Desitin Maximum Strength Zinc Oxide Diaper Rashzinc oxide | Zinc oxide 400 mg/g | PasteTopical | Kenvue Brands LLC | 69968-0396 |
| Hydrophor | Petrolatum 42 g/100g | OintmentTopical | Akron Pharma Inc. | 71399-5101 |
| Attitude Diaper Cream Zinc Unscentedzinc oxide | Zinc oxide 15 g/100g | StickTopical | 9055-7588 Quebec Inc. (Attitude) | 61649-260 |
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