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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Body Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9d86fc-ef32-baed-e063-6394a90a7d742026-03-12WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact 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