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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Eczema ReliefCOLLOIDAL OATMEALOld East Main Co.b2dba027-c295-4a41-8d30-144904e1aa342026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEChain Drug Marketing Association1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6932026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEThe Kroger Co.fcffbe1f-79b8-451a-9384-19533b81d8c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEThe Kroger Co.ea8b186c-82d5-4552-bcce-03e56023ea992026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDESmalls Brand LLC DBA Roe Wellness4bd29285-29b4-5d57-e063-6294a90af4812026-02-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWalmart Inc.320bcbd3-9e91-437f-99c5-066f880a4b322026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Soothing MoisturizingCOLLOIDAL OATMEALWalmart Inc.2d813455-c268-4c6d-9952-eaf0e0007d902026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Rapid Repair Healing CreamALLANTOIN, DIMETHICONEJune Jacobs Labs LLC186c13be-5e41-b9c9-e063-6294a90ad5742026-02-26WarningsExact identifier
application number: M016
LanashieldLANOLINDynarex Corporation94b277dc-6512-4d36-8485-8ea5100974282026-02-26WarningsExact identifier
application number: M016
GLADSKIN ECZEMACT ECZEMACOLLOIDAL OATMEALMicreos North America, Inc.06f9af75-c5ff-d37b-e063-6394a90a4f6c2026-02-25WarningsExact 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