FDA.reportPublic FDA data

CAREALL Zinc Oxide

Product NDC
51824-032
11-digit product format
518240032
Labeler code
51824
Product ID
51824-032_44ec1a8a-6db0-7207-e063-6394a90a8740
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
New World Imports Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-04
Substance
ZINC OXIDE
Active strength
.2 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
CAREALL Zinc Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.2 g/g

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
aa9ae4d1-4229-4894-9eaf-8588b2867472Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-032-03CAREALL Zinc Oxide28 g in 1 TUBEOINTMENT289
51824-032-04CAREALL Zinc Oxide56 g in 1 TUBEOINTMENT569
51824-032-15CAREALL Zinc Oxide425 g in 1 JAROINTMENT4259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-032-03GM - Gram51824-032a442cc6b-4fcc-4310-a678-49940cc1373712020-03-10
51824-032-04GM - Gram51824-032cf0b2cdc-342e-4f5b-b092-6ea25ca70c7412020-03-10
51824-032-15GM - Gram51824-032c9c5c137-7fb0-4a5e-8a43-753e9ca5067c12020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZCAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZCAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXCAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SCAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPCAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2
ParaffinINACTIVE INGREDIENTI9O0E3H2ZECAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-032CAREALL ZINC OXIDE (ZINC OXIDE) OINTMENT [NEW WORLD IMPORTS INC]8Current NDC, Legacy NDC, 3 package rows20231014_aa9ae4d1-4229-4894-9eaf-8588b2867472.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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42762471-e5cd-505e-e063-6294a90afb7d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNaa9ae4d1-4229-4894-9eaf-8588b28674729
198911zinc oxide 0.2 MG/MG Topical OintmentSCDaa9ae4d1-4229-4894-9eaf-8588b28674729
198911zinc oxide 20 % Topical OintmentSYaa9ae4d1-4229-4894-9eaf-8588b28674729
198911zinc oxide 200 MG per GM Topical OintmentSYaa9ae4d1-4229-4894-9eaf-8588b28674729
198911ZNO 0.2 MG/MG Topical OintmentSYaa9ae4d1-4229-4894-9eaf-8588b28674729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-032-035182400320328 g in 1 TUBE (51824-032-03) 28 g2013-04-040000-00-00NoNoCurrent
51824-032-045182400320456 g in 1 TUBE (51824-032-04) 56 g2013-04-040000-00-00NoNoCurrent
51824-032-1551824003215425 g in 1 JAR (51824-032-15) 425 g2013-04-040000-00-00NoNoCurrent