ProCure Zinc Oxide

Product NDC
55681-017
11-digit product format
556810017
Labeler code
55681
Product ID
55681-017_4ee11cb5-7447-6745-e063-6394a90a5fbf
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Twin Med LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
ZINC OXIDE
Active strength
20 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
ProCure Zinc Oxide
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
37a30ee5-fd33-b410-e063-6294a90aef72Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-017-01ProCure Zinc Oxide28.3 g in 1 TUBEOINTMENT28.32
55681-017-02ProCure Zinc Oxide56.6 g in 1 TUBEOINTMENT56.62
55681-017-15ProCure Zinc Oxide425 g in 1 JAROINTMENT4252

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 45 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aluroderm ScarALLANTOINOlakino Therapeutics LLC2a848dde-8fc4-ab10-e063-6294a90a25832025-02-07WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijerc79352e9-d9a3-0d42-e053-2a95a90a5ea22025-02-06WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELFamily Dollar (FAMILY WELLNESS)a2047ef3-cda4-4411-a4c2-d7fb03f5b0692025-02-06WarningsExact identifier
application number: M016
First honey Burn SalveALLANTOINFirst Honey, LLCf40a9a34-1827-7171-e053-2a95a90acf312025-02-04WarningsExact identifier
application number: M016
Manuka Honey Extra StrengthALLANTOINFirst Honey LLCb742585d-9a0c-489b-b268-590583cfabd12025-02-04WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELCardinal Health (Leader) 7000036deb7de-14b0-44a4-89bb-51cc1770e65b2025-02-04WarningsExact identifier
application number: M016
NIVAGEN ZINC OXIDEZINC OXIDENivagen Pharmaceuticals, Inc.7b42655b-2163-4637-9f5d-1d2efa1bdf1d2025-02-03WarningsExact identifier
application number: M016
MATYS Baby ECZEMA RELIEFCOLLOIDAL OATMEALMatys Healthy Products LLC4c052bed-0931-4b8d-b033-b1872272c5982025-01-29WarningsExact identifier
application number: M016
MATYS Baby DIAPER RASH RELIEFZINC OXIDEMatys Healthy Products LLCf214db72-bf4f-46d7-8ffc-6333185a69d52025-01-29WarningsExact identifier
application number: M016
EARLY MOMMY Baby Bum ButtaZINC OXIDETEKT TONE LABS LLC4bd417ba-3d24-46e3-a771-3183824f02192025-01-28WarningsExact identifier
application number: M016
Rite Aid ScarALLANTOIN 0.5%Rite Aidfd152c8f-6df5-1236-e053-6394a90a865d2025-01-27WarningsExact identifier
application number: M016
BIA Eczema ReliefOATMEALCodex Labs Corporation2f2de819-b7db-4c1e-9d6e-9ce33f7e6d052025-01-27WarningsExact identifier
application number: M016
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
application number: M016
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
application number: M016
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
application number: M016
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
application number: M016
Baby XtraCare OatmealDIMETHICONERejoice International0049462b-ff31-440f-9244-b61153625bca2025-01-23WarningsExact identifier
application number: M016
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
application number: M016
Bebe BottomsZINC OXIDETARO PHARMACEUTICALS U.S.A., INC.eb8512db-f8a9-432c-8779-2971411ce43d2025-01-21WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLC2c2337cf-4507-7232-e063-6294a90a79c32025-01-20WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN37a30ee5-fd33-b410-e063-6294a90aef722
198911zinc oxide 0.2 MG/MG Topical OintmentSCD37a30ee5-fd33-b410-e063-6294a90aef722
198911zinc oxide 20 % Topical OintmentSY37a30ee5-fd33-b410-e063-6294a90aef722
198911zinc oxide 200 MG per GM Topical OintmentSY37a30ee5-fd33-b410-e063-6294a90aef722
198911ZNO 0.2 MG/MG Topical OintmentSY37a30ee5-fd33-b410-e063-6294a90aef722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-017-015568100170128.3 g in 1 TUBE (55681-017-01) 28.3 g2025-06-16NoNoCurrent
55681-017-025568100170256.6 g in 1 TUBE (55681-017-02) 56.6 g2025-06-16NoNoCurrent
55681-017-1555681001715425 g in 1 JAR (55681-017-15) 425 g2025-06-16NoNoCurrent