Zinc Oxide 20%

Product NDC
69396-086
11-digit product format
693960086
Labeler code
69396
Product ID
69396-086_0f4e022b-3f1e-96dc-e063-6294a90ad3b7
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-30
Substance
ZINC OXIDE
Active strength
.2 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Zinc Oxide 20%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.2 g/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
fcef17f1-84e7-a288-e053-6294a90a064bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-086-02Zinc Oxide 20%60 g in 1 TUBEOINTMENT602
69396-086-02Zinc Oxide 20%1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-086ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]2Current NDC, 2 package rows20240120_fcef17f1-84e7-a288-e053-6294a90a064b.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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Arthcal Bioidentical Peach CreamARTHCAL BIOIDENTICAL PEACH CREAMBeijing JUNGE Technology Co., Ltd.3c77f787-b7dd-6813-e063-6394a90aa0042025-08-16Boxed warning, WarningsExact identifier
application number: M016
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
application number: M016
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
application number: M016
AmeriDerm PeriShieldZINC OXIDEShield Line LLC417f1541-d65a-4612-b96b-e6183fbef1f32025-08-15WarningsExact identifier
application number: M016
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNfcef17f1-84e7-a288-e053-6294a90a064b2
198911zinc oxide 0.2 MG/MG Topical OintmentSCDfcef17f1-84e7-a288-e053-6294a90a064b2
198911zinc oxide 20 % Topical OintmentSYfcef17f1-84e7-a288-e053-6294a90a064b2
198911zinc oxide 200 MG per GM Topical OintmentSYfcef17f1-84e7-a288-e053-6294a90a064b2
198911ZNO 0.2 MG/MG Topical OintmentSYfcef17f1-84e7-a288-e053-6294a90a064b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-086-02693960086021 TUBE in 1 BOX (69396-086-02) / 60 g in 1 TUBE1 tube2023-05-30NoNoCurrent