FDA.reportPublic FDA data

Skin Protectant

Product NDC
70000-0488
11-digit product format
700000488
Labeler code
70000
Product ID
70000-0488_5d2ebc9a-cdd4-34f8-e063-6294a90abefe
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 25%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-16
Substance
ZINC OXIDE
Active strength
25 mg/100mg
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
Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE25 mg/100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0488-1Skin Protectant72 in 1 CASEOINTMENT729
70000-0488-1Skin Protectant1 in 1 BOXOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0488-1GM - Gram70000-0488bcb23a65-72e1-49a0-a82a-2ed2811da35f12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0488SKIN PROTECTANT (ZINC OXIDE 25%) OINTMENT [CARDINAL HEALTH]8Current NDC, Legacy NDC, 2 package rows20241127_8abda4ad-2ef7-9428-e053-2a95a90ac0fb.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238405zinc oxide 25 % Topical OintmentPSN8abda4ad-2ef7-9428-e053-2a95a90ac0fb9
238405zinc oxide 0.25 MG/MG Topical OintmentSCD8abda4ad-2ef7-9428-e053-2a95a90ac0fb9
238405zinc oxide 25 % Topical OintmentSY8abda4ad-2ef7-9428-e053-2a95a90ac0fb9
238405ZNO 0.25 MG/MG Topical OintmentSY8abda4ad-2ef7-9428-e053-2a95a90ac0fb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0488-17000004880172 BOX in 1 CASE (70000-0488-1) / 1 TUBE in 1 BOX / 28400 mg in 1 TUBE72 box2019-01-160000-00-00NoNoCurrent