FDA.reportPublic FDA data

Endit zinc oxide skin protection

Product NDC
64068-500
11-digit product format
640680500
Labeler code
64068
Product ID
64068-500_47f5517a-46c6-6d06-e063-6394a90aa5c9
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
EndIt Laboratories, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-09
Substance
ZINC OXIDE
Active strength
200 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
Endit zinc oxide skin protection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 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
198911Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e60bb0da-3349-f8f9-e053-2a95a90a9051Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64068-500-01Endit zinc oxide skin protection56.7 g in 1 JAROINTMENT56.73
64068-500-02Endit zinc oxide skin protection113.4 g in 1 JAROINTMENT113.43
64068-500-03Endit zinc oxide skin protection227 g in 1 JAROINTMENT2273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64068-500ENDIT ZINC OXIDE SKIN PROTECTION (ZINC OXIDE) OINTMENT [ENDIT LABORATORIES, INC.]2Current NDC, Legacy NDC, 3 package rows20231215_e60bb0da-3349-f8f9-e053-2a95a90a9051.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 24 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
application number: M016
HydrocortisoneDRS. HYDROCORTISONEOL PHARMA TECH,LLCb0eac8f3-bb80-6563-e053-2995a90a83c92026-01-22WarningsExact identifier
application number: M016
Eczema Reliegf Skin Protectant EQBCOLLOIDAL OATMEAL 2%Walmart37132a0d-37c5-4b21-9673-5f853b3a62482026-01-20WarningsExact identifier
application number: M016
Skin Relief CreamHYDROCORTISONESpa de Soleil0a90b77a-4be4-71c5-e063-6294a90a8e412026-01-20WarningsExact identifier
application number: M016
Cold Sore BandageCOLD SORE BANDAGEShenzhen Hengdasheng Technology Co., Ltd47f588a2-a69b-cffe-e063-6294a90a0ed42026-01-17WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.48793a50-89a7-dba9-e063-6394a90a70562026-01-16WarningsExact identifier
application number: M016
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
application number: M016
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKINDIMETHICONESolvChem, Inc.da12ac2c-1af9-47b1-aa5f-77acb48535ba2026-01-16WarningsExact identifier
application number: M016
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
application number: M016
INCONTINENCE CARE WIPEDIMETHICONECardinal Health 200, Inc.1ac34c94-9e3b-45f2-ba19-a07dcd3941dd2026-01-15WarningsExact identifier
application number: M016
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
application number: M016
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact identifier
application number: M016
GG XEROZINE 15SKIN PROTECTANTGERI-GENTLE CORPORATIONe6881c6d-f584-26d0-e053-2995a90a38732026-01-14WarningsExact identifier
application number: M016
Medpura Zinc Oxide 20%MEDPURA ZINC OXIDE 20%Akron Pharma Inc.3a63aaea-087e-4115-8478-64d416e6085f2026-01-14WarningsExact identifier
application number: M016
Walgreens Baby PetroleumPETROLATUMWalgreen Companye79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d2026-01-14WarningsExact identifier
application number: M016
Walgreens Cocoa Butter JellyPETROLEUMWalgreens32b84286-471a-4d15-80fb-2f516dc1d6ea2026-01-14WarningsExact identifier
application number: M016
Hydrating Healing Skin ProtectantPETROLATUM OINTMENTCVS Pharmacyc129c2b0-10d5-4b5d-ac5c-2e2512e612792026-01-14WarningsExact identifier
application number: M016
Multi-Purpose Skin ProtectantA AND D OINTMENTCVS Pharmacy60bd0095-25d3-44af-9502-0c63b3d25e662026-01-14WarningsExact identifier
application number: M016
Kenkoderm Eczema Honey Intensive Soothing BalmKENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALMGuangzhou Ariel Biotech Co., Ltd.48652b9c-4063-cc16-e063-6394a90a3b862026-01-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNe60bb0da-3349-f8f9-e053-2a95a90a90513
198911zinc oxide 0.2 MG/MG Topical OintmentSCDe60bb0da-3349-f8f9-e053-2a95a90a90513
198911zinc oxide 20 % Topical OintmentSYe60bb0da-3349-f8f9-e053-2a95a90a90513
198911zinc oxide 200 MG per GM Topical OintmentSYe60bb0da-3349-f8f9-e053-2a95a90a90513
198911ZNO 0.2 MG/MG Topical OintmentSYe60bb0da-3349-f8f9-e053-2a95a90a90513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64068-500-016406805000156.7 g in 1 JAR (64068-500-01) 56.7 g2022-08-090000-00-00NoNoCurrent
64068-500-0264068050002113.4 g in 1 JAR (64068-500-02) 113.4 g2022-08-090000-00-00NoNoCurrent
64068-500-0364068050003227 g in 1 JAR (64068-500-03) 227 g2022-08-090000-00-00NoNoCurrent