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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VITACILINA Bebe Diaper Rash
Listing expiration
2026-12-31

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 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact 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