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 | 8336900020183369000201 | 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 |
|---|---|---|---|---|
| 2-Pack Facial Serum | Water 78.894 g/100mL + 4 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-011 |
| 2-Pack Facial Serum | 3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-012 |
| 3M Cavilon Durable Barrierdimethicone | Dimethicone 13000 mg/L | CreamTopical | Solventum US LLC | 17518-030 |
| 4% 10gTATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-031 |
| 4% TATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-030 |
| 456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis root | Salicylic acid 380 mg/50g + 3 more ingredients | CreamTopical | Guangzhou Senmai Biotechnology Co.,Ltd. | 84509-111 |
| 5% Dr.care Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-028 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-328 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-329 |
| 5% Minoxidil | Biotin .05 g/100g; Niacinamide 2.5 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-335 |
| 5% Minoxidil | Minoxidil 5 g/100g + 5 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-337 |
| 5% Minoxidil for Men and Women | Biotin .05 g/100g; Tocopherol .05 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-332 |
| 5% Minoxidil Hair Growth | Biotin .1 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-333 |
| 5% Minoxidil Hair Growth | Minoxidil 5 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-334 |
| 5% Signature Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-026 |
| 5% Signature Numb cream5% signature | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-027 |
| 5% Signature Numb cream5% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-029 |
| 70% Isopropyl Rubbing Alcoholisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | LiquidTopical | MY IMPORTS USA LLC | 51628-4501 |
| 911allantoin | Allantoin .5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-120 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
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