NDC 54312-525

VITACILINA Bebe Diaper Rash

Allantoin, Zinc Oxide

VITACILINA Bebe Diaper Rash is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Compania Internacional De Comercio, S.a.p.i De C.v.. The primary component is Allantoin; Zinc Oxide.

• Product ID: 54312-525_7d7c71fb-0cc0-614a-e053-2a91aa0ae575
• NDC: 54312-525
• Product Type: Human Otc Drug
• Proprietary Name: VITACILINA Bebe Diaper Rash
• Generic Name: Allantoin, Zinc Oxide
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-09-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Compania Internacional de Comercio, S.A.P.I de C.V.
• Substance Name: ALLANTOIN; ZINC OXIDE
• Active Ingredient Strength: 10 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54312-525-16

1 TUBE in 1 PACKAGE (54312-525-16) > 50 g in 1 TUBE

• Marketing Start Date: 2013-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54312-525-16 [54312052516]

VITACILINA Bebe Diaper Rash OINTMENT

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-09-30

Drug Details

Active Ingredients

Ingredient	Strength
ALLANTOIN	10 mg/g

OpenFDA Data

• SPL SET ID: 39726b59-bd85-4541-80e5-4f2919842dca
• Manufacturer:
  • Compania Internacional de Comercio, S.A.P.I de C.V.
• UNII:
  • SOI2LOH54Z
  • 344S277G0Z
• RxNorm Concept Unique ID - RxCUI:
  • 1441179
  • 1441184

NDC Crossover Matching brand name "VITACILINA Bebe Diaper Rash" or generic name "Allantoin, Zinc Oxide"

NDC	Brand Name	Generic Name
54312-525	VITACILINA Bebe Diaper Rash	ALLANTOIN, ZINC OXIDE
81929-002	Vitacilina Bebe Diaper Rash	ZINC OXIDE