FDA.reportPublic FDA data

KURADOR

Product NDC
84058-140
11-digit product format
840580140
Labeler code
84058
Product ID
84058-140_5c165231-b642-52d8-e063-6394a90aad81
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
LABORATORIOS H.G. C.A.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-29
Substance
ZINC OXIDE
Active strength
18.75 g/100g
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
KURADOR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18.75 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84058-140-958405801409512 CAN in 1 BOX (84058-140-95) / 11 g in 1 CAN12 can2026-09-29NoNoCurrent