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 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 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