FDA.reportPublic FDA data

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
IngredientStrength
ALLANTOIN10 mg/g
ZINC OXIDE250 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1441179Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39726b59-bd85-4541-80e5-4f2919842dcaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-525-16VITACILINA Bebe Diaper Rash1 in 1 PACKAGEOINTMENT120
54312-525-16VITACILINA Bebe Diaper Rash50 g in 1 TUBEOINTMENT5020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
ALLANTOINACTIVE MOIETY344S277G0ZVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
LANOLININACTIVE INGREDIENT7EV65EAW6HVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
VITAMIN AINACTIVE INGREDIENT81G40H8B0TVITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]5
VITAMIN DINACTIVE INGREDIENT9VU1KI44GPVITACILINA 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
NDCDashboard titleSPL versionValidationDashboard ZIP
54312-525VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]16Current NDC, Legacy NDC, 2 package rows20241031_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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441179allantoin 1 % / zinc oxide 25 % Topical OintmentPSN39726b59-bd85-4541-80e5-4f2919842dca20
1441179allantoin 0.01 MG/MG / zinc oxide 0.25 MG/MG Topical OintmentSCD39726b59-bd85-4541-80e5-4f2919842dca20
1441179Allantoin 0.01 MG/MG / ZNO 0.25 MG/MG Topical OintmentSY39726b59-bd85-4541-80e5-4f2919842dca20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54312-525-16543120525161 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE1 tube2013-09-300000-00-00NoNoCurrent