Zinc Oxide

Product NDC
69771-109
11-digit product format
697710109
Labeler code
69771
Product ID
69771-109_3ff42319-2fba-acb9-e063-6294a90a4129
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Geri-Gentle Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-15
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69771-109-38ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69771-109-39ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69771-109-38367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69771-109-39367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69771-109-38557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69771-109-39557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69771-109-388af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69771-109-398af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69771-109-38834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69771-109-39834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69771-109-381332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69771-109-391332a3947898…d4bfe170f9cd…

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
Listing expiration
2026-12-31

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
f5cfab62-8aab-4109-b15b-4fe380f7cb9eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69771-109-382025-01-06Zinc Oxide
69771-109-392025-01-06Zinc Oxide
69771-109-382023-01-30Zinc Oxide
69771-109-392023-01-30Zinc Oxide
69771-109-382020-02-04Zinc Oxide
69771-109-392020-02-04Zinc Oxide
69771-109-382020-01-31Zinc Oxide
69771-109-392020-01-31Zinc Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-109-38Zinc Oxide1 in 1 BOXOINTMENT16
69771-109-38Zinc Oxide28.4 g in 1 TUBEOINTMENT28.46
69771-109-39Zinc Oxide1 in 1 BOXOINTMENT16
69771-109-39Zinc Oxide56.8 g in 1 TUBEOINTMENT56.86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-109ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]5Current NDC, Legacy NDC, 4 package rows20250108_f5cfab62-8aab-4109-b15b-4fe380f7cb9e.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 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 OintmentPSNf5cfab62-8aab-4109-b15b-4fe380f7cb9e6
198911zinc oxide 0.2 MG/MG Topical OintmentSCDf5cfab62-8aab-4109-b15b-4fe380f7cb9e6
198911zinc oxide 20 % Topical OintmentSYf5cfab62-8aab-4109-b15b-4fe380f7cb9e6
198911zinc oxide 200 MG per GM Topical OintmentSYf5cfab62-8aab-4109-b15b-4fe380f7cb9e6
198911ZNO 0.2 MG/MG Topical OintmentSYf5cfab62-8aab-4109-b15b-4fe380f7cb9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69771-109-38697710109381 TUBE in 1 BOX (69771-109-38) / 28.4 g in 1 TUBE1 tube2017-01-150000-00-00NoNoCurrent
69771-109-39697710109391 TUBE in 1 BOX (69771-109-39) / 56.8 g in 1 TUBE1 tube2017-01-150000-00-00NoNoCurrent