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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact 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