vitacilina bebe diaper rash

Generic: allantoin, zinc oxide

Labeler: compania internacional de comercio, s.a.p.i de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name vitacilina bebe diaper rash
Generic Name allantoin, zinc oxide
Labeler compania internacional de comercio, s.a.p.i de c.v.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

allantoin 10 mg/g, zinc oxide 250 mg/g

Manufacturer
Compania Internacional de Comercio, S.A.P.I de C.V.

Identifiers & Regulatory

Product NDC 54312-525
Product ID 54312-525_471d2450-a938-69cf-e063-6294a90ac7c1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2013-09-30

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54312525
Hyphenated Format 54312-525

Supplemental Identifiers

RxCUI
1441179
UPC
0354312225164
UNII
344S277G0Z SOI2LOH54Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vitacilina bebe diaper rash (source: ndc)
Generic Name allantoin, zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
  • 250 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE
source: ndc

Packages (1)

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

Ingredients (2)

allantoin (10 mg/g) zinc oxide (250 mg/g)

Linked Drug Pages (1)

VITACILINA Bebe Diaper Rash ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "471d2450-a938-69cf-e063-6294a90ac7c1", "openfda": {"upc": ["0354312225164"], "unii": ["344S277G0Z", "SOI2LOH54Z"], "rxcui": ["1441179"], "spl_set_id": ["39726b59-bd85-4541-80e5-4f2919842dca"], "manufacturer_name": ["Compania Internacional de Comercio, S.A.P.I de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (54312-525-16)  / 50 g in 1 TUBE", "package_ndc": "54312-525-16", "marketing_start_date": "20130930"}], "brand_name": "VITACILINA Bebe Diaper Rash", "product_id": "54312-525_471d2450-a938-69cf-e063-6294a90ac7c1", "dosage_form": "OINTMENT", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "54312-525", "generic_name": "ALLANTOIN, ZINC OXIDE", "labeler_name": "Compania Internacional de Comercio, S.A.P.I de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "VITACILINA Bebe Diaper Rash", "active_ingredients": [{"name": "ALLANTOIN", "strength": "10 mg/g"}, {"name": "ZINC OXIDE", "strength": "250 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130930", "listing_expiration_date": "20261231"}