FDA.reportPublic FDA data

Vitacilina Bebe Diaper Rash

Product NDC
81929-002
11-digit product format
819290002
Labeler code
81929
Product ID
81929-002_3bc68c66-c125-1bcc-e063-6394a90a0e63
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taisho Pharmaceutical California Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Marketing end
2027-10-17
Substance
ZINC OXIDE
Active strength
400 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6701e929-700e-40a4-9117-81e36577bfe1Available 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
81929-002-01Vitacilina Bebe Diaper Rash50 g in 1 TUBEOINTMENT503
81929-002-01Vitacilina Bebe Diaper Rash1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81929-002VITACILINA BEBE DIAPER RASH (ZINC OXIDE) OINTMENT [TAISHO PHARMACEUTICAL CALIFORNIA INC.]2Current NDC, Legacy NDC, 2 package rows20231111_6701e929-700e-40a4-9117-81e36577bfe1.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 23 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
application number: M016
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
application number: M016
Zinc oxideZINC OXIDEAldi, Incd56782c1-b23c-47a9-82cb-d7dbb0ac7aa32026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
DAILY MOISTURIZINGDIMETHICONE LOTIONAldi, Inc4ad18f4a-e148-4bf5-a04b-4168fa48eeb22026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALAldi, Inc79f498af-c207-4f85-bf1b-fb2ee8379fd82026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
application number: M016
Equate Scar TopicalALLANTOINWalMartcf511a02-355c-4286-82fa-6f0c4a2448232026-01-29WarningsExact identifier
application number: M016
TriDerma Stubborn Diaper Rash ReliefALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporationf8f3ae0b-aa55-4c2f-8823-54268524917b2026-01-28WarningsExact identifier
application number: M016
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M016
Equate Chafing GelDIMETHICONEWalmart Inc06665504-040c-a806-e063-6294a90acedc2026-01-27WarningsExact identifier
application number: M016
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
application number: M016
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
application number: M016
XIMONTH Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49451717-e41c-8ae0-e063-6294a90a91ad2026-01-26WarningsExact identifier
application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated SoakALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.09a178c1-0eb1-43e5-bde8-fd27ed633d592026-01-26WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244638zinc oxide 40 % Topical OintmentPSN6701e929-700e-40a4-9117-81e36577bfe13
244638zinc oxide 0.4 MG/MG Topical OintmentSCD6701e929-700e-40a4-9117-81e36577bfe13
244638zinc oxide 40 % Topical OintmentSY6701e929-700e-40a4-9117-81e36577bfe13
244638ZNO 0.4 MG/MG Topical OintmentSY6701e929-700e-40a4-9117-81e36577bfe13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81929-002-01819290002011 TUBE in 1 CARTON (81929-002-01) / 50 g in 1 TUBE1 tube2022-07-012027-10-17NoNoCurrent