Home NDC 54312-525 VITACILINA Bebe Diaper Rash
Product NDC 54312-525
11-digit product format 543120525
Labeler code 54312
Product ID 54312-525_471d2450-a938-69cf-e063-6294a90ac7c1
Type HUMAN OTC DRUG
Nonproprietary name ALLANTOIN, ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler Compania Internacional de Comercio, S.A.P.I de C.V.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-09-30
Substance ALLANTOIN; ZINC OXIDE
Active strength 10; 250 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base VITACILINA Bebe Diaper Rash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN 10 mg/g ZINC OXIDE 250 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 344S277G0Z Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1441179 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54312-525-16 VITACILINA Bebe Diaper Rash 1 in 1 PACKAGE OINTMENT 1 20 54312-525-16 VITACILINA Bebe Diaper Rash 50 g in 1 TUBE OINTMENT 50 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALLANTOIN ACTIVE INGREDIENT 344S277G0Z VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 ALLANTOIN ACTIVE MOIETY 344S277G0Z VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 VITAMIN A INACTIVE INGREDIENT 81G40H8B0T VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5 VITAMIN D INACTIVE INGREDIENT 9VU1KI44GP VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54312-525 VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 16 Current NDC, Legacy NDC, 2 package rows 20241031_39726b59-bd85-4541-80e5-4f2919842dca.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier application number: M016 MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier application number: M016 Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 3e61191a-e0fa-3477-e063-6294a90a7d19 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 459a90b8-7d52-ef70-e063-6394a90ac1d0 2026-07-14 Warnings Exact identifier application number: M016 Mederma for Kids ALLANTOIN L. Perrigo Company ed4ff435-9819-46d3-9375-914712943f77 2026-07-14 Warnings Exact identifier application number: M016 Baby 3-in-1 Diaper Rash BABY 3-IN-1 DIAPER RASH Walgreens 5632dde2-f59d-3a45-e063-6394a90a1a24 2026-07-09 Warnings Exact identifier application number: M016 Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier application number: M016 Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Exact identifier application number: M016 SOHEJU Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 560089ff-3361-90b7-e063-6294a90ada42 2026-07-09 Warnings Exact identifier application number: M016 Bee Venom Psoriasis Wart Caring Cream GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 563a423c-e9dd-1cab-e063-6294a90a8c6a 2026-07-09 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson Medical-Surgical Inc. 46df52c8-0cbf-213e-e054-00144ff88e88 2026-07-08 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson 5abe1b34-f71b-2a90-e053-2991aa0aded6 2026-07-08 Warnings Exact identifier application number: M016 Walgreens Baby Healing Balm PETROLATUM Walgreens 561c1e1e-e896-d6e9-e063-6394a90ac0e7 2026-07-08 Warnings Exact identifier application number: M016 AD Overnight Healing AD OVERNIGHT HEALING WellSpring Pharmaceutical Corporation 57c29db6-da0c-4b28-86c0-6ac1b7122428 2026-07-07 Warnings Exact identifier application number: M016 EczeNourish Eczema and Psoriasis Soothing Oat COLLOIDAL OATMEAL Vanguard Soap, LLC 55f7137f-c5a5-f2ce-e063-6394a90a5280 2026-07-07 Warnings Exact identifier application number: M016 FDS intimate Whole Body Medicated Chafing FDS INTIMATE WHOLE BODY MEDICATED CHAFING WellSpring Pharmaceutical Corporation ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c 2026-07-07 Warnings Exact identifier application number: M016 AD First Aid Multipurpose AD FIRST AID MULTIPURPOSE WellSpring Pharmaceutical Corporation 999989d8-21c2-4380-b4c1-e5421189f6ed 2026-07-07 Warnings Exact identifier application number: M016 AD Anti-Chafing AD ANTI-CHAFING WellSpring Pharmaceutical Corporation d272ab4a-eb18-4f64-b925-fccf637dbb02 2026-07-06 Warnings Exact identifier application number: M016 ECZEMA NOURISH MEDICATED CLEANSING BAR COLLOIDAL OATMEAL SKIN PROTECTANT Vanguard Soap, LLC 55f865dc-d88e-fe2f-e063-6294a90aa7d3 2026-07-06 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54312-525-16 54312052516 1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE 1 tube 2013-09-30 0000-00-00 No No Current