Over-the-counter drug · OTC MONOGRAPH DRUG
Dr. Sheffield Diaper Rash (Zinc oxide) NDC 11527-058
Zinc oxide 400 mg/g · Ointment · Topical · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-058-40 | 11527005840 | 1 TUBE in 1 CARTON (11527-058-40) / 28 g in 1 TUBEMarketed from Jan 17, 2014 | |
| 11527-058-41 | 11527005841 | 1 TUBE in 1 CARTON (11527-058-41) / 56 g in 1 TUBEMarketed from Jan 9, 2002 |
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)
- Dr. Sheffield Diaper Rash
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — 400 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Sheffield Pharmaceuticals LLCNDC labeler code 11527
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 11527-058_569610c1-6c56-4437-a651-2004d621d8acSPL ID 569610c1-6c56-4437-a651-2004d621d8acSPL set ID cac77320-b5cf-4edf-9693-ebabfb61390cRxCUI 244638UNII 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
N411527005840followed by a unit qualifier and the quantityPackage 11527-0058-40. 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 helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Excerpt only. Read the full label for complete information.
About NDC 11527-058
- What is NDC 11527-058?
- 11527-058 is the product NDC for Dr. Sheffield Diaper Rash (zinc oxide), Zinc oxide 400 mg/g ointment, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dr. Sheffield Diaper Rash (Zinc Oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- Sheffield Pharmaceuticals LLC, NDC labeler code 11527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dr. Sheffield Diaper Rash?
- 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 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 |
Showing 20 of 40.