FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui198911

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-109-382025-01-06C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392025-01-06C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382023-01-30C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392023-01-30C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382020-02-04C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392020-02-04C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-382020-01-31C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc Oxide
69771-109-392020-01-31C16284748780-19d75b9cf-f9bc-f424-e053-dadaa90a57ceZinc 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

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