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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact 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