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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unilevera735d885-bacd-0f5c-e053-2a95a90ad14a2024-10-24WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZERConopco Inc. d/b/a/ Unileverb8dc481c-1ac3-2d63-e053-2a95a90a44f52024-10-24WarningsExact identifier
application number: M016
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverd1039316-3ca8-90f8-e053-2995a90a20612024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.130d94d8-ad98-d61f-e063-6294a90a76b02024-10-21WarningsExact identifier
application number: M016
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
application number: M016
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact 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