FDA.reportPublic FDA data

Zinc Oxide 20%

Product NDC
69396-021
Requested package NDC
69396-021-54
11-digit product format
693960021
Labeler code
69396
Product ID
69396-021_521c0f8d-c99e-0b87-e063-6294a90abdbc
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
2018-01-26
Substance
ZINC OXIDE
Active strength
.2 g/g
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
Zinc Oxide 20%
Listing expiration
2027-12-31

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
63b551fc-7d16-c099-e053-2a91aa0a5f2cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
69396-021-542023-04-24f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-04-24f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-01-30f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-01-30f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-022021-08-11ba0f9c33-55c4-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
69396-021-022021-08-11ba0f9c33-55c4-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
69396-021-012021-01-29ba0f9c33-4bbf-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
69396-021-022021-01-29ba0f9c33-55c4-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
69396-021-022021-01-29ba0f9c33-55c4-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-021-54Zinc Oxide 20%1 in 1 JAROINTMENT19
69396-021-54Zinc Oxide 20%454 g in 1 JAROINTMENT4549
69396-021-02Zinc Oxide 20%1 in 1 BOXOINTMENT17
69396-021-02Zinc Oxide 20%60 g in 1 TUBEOINTMENT607
69396-021-01Zinc Oxide 20%28 g in 1 TUBEOINTMENT282
69396-021-01Zinc Oxide 20%1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-021-02GM - Gram69396-021198fd2a0-5e55-4d19-b613-89aaa71a142112022-05-04
69396-021-54GM - Gram69396-02117e82a94-c616-4a21-9e5c-b4da32753d8b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-021ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]8Current NDC, Legacy NDC, 2 package rows20241222_8cbe9b1f-fec0-9579-e053-2995a90ac461.zip
69396-021ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]4Current NDC, Legacy NDC, 2 package rows20250112_63b551fc-7d16-c099-e053-2a91aa0a5f2c.zip
69396-021ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]2Current NDC, Legacy NDC, 2 package rows20180126_61f5aefe-9b43-a616-e053-2a91aa0acdbc.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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN8cbe9b1f-fec0-9579-e053-2995a90ac4619
198911zinc oxide 0.2 MG/MG Topical OintmentSCD8cbe9b1f-fec0-9579-e053-2995a90ac4619
198911zinc oxide 20 % Topical OintmentSY8cbe9b1f-fec0-9579-e053-2995a90ac4619
198911zinc oxide 200 MG per GM Topical OintmentSY8cbe9b1f-fec0-9579-e053-2995a90ac4619
198911ZNO 0.2 MG/MG Topical OintmentSY8cbe9b1f-fec0-9579-e053-2995a90ac4619
198911zinc oxide 20 % Topical OintmentPSN63b551fc-7d16-c099-e053-2a91aa0a5f2c7
198911zinc oxide 0.2 MG/MG Topical OintmentSCD63b551fc-7d16-c099-e053-2a91aa0a5f2c7
198911zinc oxide 20 % Topical OintmentSY63b551fc-7d16-c099-e053-2a91aa0a5f2c7
198911zinc oxide 200 MG per GM Topical OintmentSY63b551fc-7d16-c099-e053-2a91aa0a5f2c7
198911ZNO 0.2 MG/MG Topical OintmentSY63b551fc-7d16-c099-e053-2a91aa0a5f2c7
198911zinc oxide 20 % Topical OintmentPSN61f5aefe-9b43-a616-e053-2a91aa0acdbc2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD61f5aefe-9b43-a616-e053-2a91aa0acdbc2
198911zinc oxide 20 % Topical OintmentSY61f5aefe-9b43-a616-e053-2a91aa0acdbc2
198911zinc oxide 200 MG per GM Topical OintmentSY61f5aefe-9b43-a616-e053-2a91aa0acdbc2
198911ZNO 0.2 MG/MG Topical OintmentSY61f5aefe-9b43-a616-e053-2a91aa0acdbc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-021-54693960021541 JAR in 1 JAR (69396-021-54) / 454 g in 1 JAR1 jar2019-07-010000-00-00NoNoCurrent