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 22 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetroleumWHITE PETROLATUMHarris Teeterde380df6-cc6e-4b2a-98de-fc08eeb6e8ea2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLCc82f236d-c27f-458c-bcd8-19877d09e9a32026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLC5e83811f-773f-43e7-bab8-f9e558fb0e002026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d76e116f-4b22-4633-8487-17ad3b5778c72026-02-04WarningsExact identifier
application number: M016
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
application number: M016
Daily MoisturizingDIMETHICONECVS Pharmacy, Inc.edc20df4-561e-486f-b9f1-900672a0f2a42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.a153842c-d9ce-4658-912b-362a6f20b0aa2026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMDemoulas Super Markets, Inc702215f0-4cfd-4a23-b47a-da691c1366342026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
NeurexaCOLLOIDAL OATMEALMETHODIQ INC.494d7915-acad-260e-e063-6394a90a182c2026-02-03WarningsExact identifier
application number: M016
Thera Plus Vitamin A and D CreamDIMETHICONE, ZINC OXIDEFOURSTAR GROUP USA, INC.36f09fa4-a3b8-4104-9745-ee60aa493b062026-02-02WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMKroger Co.b4aa9b58-d95e-4dac-9a34-213482e8ca342026-02-02Warnings, Adverse reactionsExact identifier
application number: M016
Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49e45462-a05f-d370-e063-6394a90a1e0f2026-02-02WarningsExact identifier
application number: M016
Barrier Repair CreamCREAMSteel City Health Private Limited4842f653-7137-eca4-e063-6394a90a8c552026-01-31WarningsExact identifier
application number: M016
Cracked Heel Repair BalmDIMETHICONEDelta Brands Inc.42b7c9f8-0557-8e33-e063-6394a90a59192026-01-30WarningsExact identifier
application number: M016
Readybath TPC Total Perineal CareDIMETHICONEMedline Industries, Inc.43a3f0f7-f76f-434d-a21f-7eaa3638913d2026-01-30WarningsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDERite Aid Corporation3af9f0e5-0d79-4178-b29e-3b60735bf4ce2026-01-30Warnings, Adverse reactionsExact 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