FDA.reportPublic FDA data

Endit Zinc Oxide Skin Protectant

Product NDC
64068-402
11-digit product format
640680402
Labeler code
64068
Product ID
64068-402_47f5536e-340b-7f85-e063-6394a90ad4a4
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
2017-05-31
Substance
ZINC OXIDE
Active strength
20 g/100g
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct64068-402EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64068-40264068-402-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

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
55b3aa07-871d-421b-b76a-c2d359d6003fAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-24Endit! Zinc Oxide Skin Protectant
2020-02-24Endit! Zinc Oxide Skin Protectant
2020-01-31Endit! Zinc Oxide Skin Protectant
2020-01-31Endit! Zinc Oxide Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64068-402-01Endit Zinc Oxide Skin Protectant454 g in 1 JAROINTMENT4547

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64068-402ENDIT ZINC OXIDE SKIN PROTECTANT (ZINC OXIDE) OINTMENT [ENDIT LABORATORIES, INC.]6Current NDC, Legacy NDC, 1 package rows20231215_55b3aa07-871d-421b-b76a-c2d359d6003f.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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN55b3aa07-871d-421b-b76a-c2d359d6003f7
198911zinc oxide 0.2 MG/MG Topical OintmentSCD55b3aa07-871d-421b-b76a-c2d359d6003f7
198911zinc oxide 20 % Topical OintmentSY55b3aa07-871d-421b-b76a-c2d359d6003f7
198911zinc oxide 200 MG per GM Topical OintmentSY55b3aa07-871d-421b-b76a-c2d359d6003f7
198911ZNO 0.2 MG/MG Topical OintmentSY55b3aa07-871d-421b-b76a-c2d359d6003f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64068-402-0164068040201454 g in 1 JAR (64068-402-01) 454 g2017-05-310000-00-00NoNoCurrent