Over-the-counter drug · OTC MONOGRAPH DRUG
VITACILINA Bebe Diaper Rash (Allantoin, zinc oxide) NDC 54312-525
Allantoin 10 mg/g; Zinc oxide 250 mg/g · Ointment · Topical · Compania Internacional de Comercio, S.A.P.I de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54312-525-16 | 5431205251654312052516 | 1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBEMarketed from Sep 30, 2013 |
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)
- VITACILINA Bebe Diaper Rash
- Generic name (nonproprietary)
- allantoin, zinc oxide
- Active ingredients
- Allantoin — 10 mg/gZinc oxide — 250 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Compania Internacional de Comercio, S.A.P.I de C.V.NDC labeler code 54312
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 54312-525_471d2450-a938-69cf-e063-6294a90ac7c1SPL ID 471d2450-a938-69cf-e063-6294a90ac7c1SPL set ID 39726b59-bd85-4541-80e5-4f2919842dcaRxCUI 1441179UNII 344S277G0Z, SOI2LOH54ZUPC 0354312225164
- Pharmacologic class
- Copper Absorption Inhibitor
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
N454312052516followed by a unit qualifier and the quantityPackage 54312-0525-16. 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 against minor skin irritation associated with diaper rash • Helps seal out wetness.
Excerpt only. Read the full label for complete information.
About NDC 54312-525
- What is NDC 54312-525?
- 54312-525 is the product NDC for VITACILINA Bebe Diaper Rash, Allantoin 10 mg/g; Zinc oxide 250 mg/g ointment, listed with the FDA by Compania Internacional de Comercio, S.A.P.I de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- VITACILINA Bebe Diaper Rash (Allantoin, Zinc oxide).
- What is the active ingredient?
- Allantoin, Zinc oxide.
- Who is the labeler?
- Compania Internacional de Comercio, S.A.P.I de C.V., NDC labeler code 54312. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for VITACILINA Bebe Diaper Rash?
- 1 other product NDC are listed under this name. See all VITACILINA Bebe Diaper Rash NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other VITACILINA Bebe Diaper Rash products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vitacilina Bebe Diaper Rashzinc oxide | Zinc oxide 400 mg/g | OintmentTopical | Taisho Pharmaceutical California Inc. | 81929-002 | 81929-0002-01 |
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 |
Showing 20 of 40.