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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
application number: M016
Gelmicin Hydrocortisone with AloeHYDROCORTISONEUnited Exchange Corp.bb64eca4-799d-4711-e053-2995a90af4032025-10-21WarningsExact identifier
application number: M016
QuadrydernHYDROCORTISONEProductos Zapotol Corpa087ad4d-9a65-19c3-e053-2995a90ab3412025-10-21WarningsExact identifier
application number: M016
VENROCKROSEMARY OILGuangzhou Oupeng Cosmetics Co., Ltd4156b669-1817-6280-e063-6394a90aaf3a2025-10-17WarningsExact identifier
application number: M016
Gerigentle-Vitamins A and DPETROLATUMGeri-Gentle Corporationc36c74f7-975b-4e4c-99e3-e6921d782c712025-10-17WarningsExact identifier
application number: M016
Seacall Dexamethasone Ointment.DEXAMETHASONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.201adf67-773c-34a2-e063-6394a90ac5252025-10-15WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LPdae45414-7401-9536-e053-2a95a90a0a862025-10-15WarningsExact identifier
application number: M016
Curology Barrier BalmSKIN BARRIER BALMCurology04b2ba38-0f81-be51-e063-6294a90af8212025-10-15WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMedline Industries, LP34f3581f-39ba-4f28-9237-52f3820ab4c02025-10-09WarningsExact identifier
application number: M016
Facial FortressPYRITHIONE ZINCPediatric Solutions, LLCcdd3c52e-4c32-46c1-bdb3-957b164190bb2025-10-08WarningsExact identifier
application number: M016
Happy CappyPYRITHIONE ZINCPediatric Solutions, LLC3d3828d8-ee15-4aff-99d1-a121f0102a002025-10-08WarningsExact identifier
application number: M016
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
application number: M016
Scar Reducer Intensive Herbal and NutrientALLANTOINQuantum, Inc5197f1fa-aae5-406c-97d9-635b8c1a88a82025-10-06WarningsExact identifier
application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTERZINC OXIDEBrand 2022b LLC40537561-d334-5859-e063-6394a90a92a72025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss originalZINC OXIDEBrand 2022b LLC4056e49a-2976-38f9-e063-6394a90a786d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Nudie roseZINC OXIDEBrand 2022b LLC4057b0e2-1c31-abae-e063-6294a90a053d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Pink coralZINC OXIDEBrand 2022b LLC405865dd-7d0e-048d-e063-6394a90ab1052025-10-04WarningsExact identifier
application number: M016
HealthWise Medicated Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare164f4cd8-975a-40d5-e063-6394a90ae7d52025-10-02WarningsExact 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