FDA.reportPublic FDA data

Rash Buster

Product NDC
83347-1844
11-digit product format
833471844
Labeler code
83347
Product ID
83347-1844_5cfbb10f-1796-3a2a-e063-6294a90a3e7f
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide paste
Dosage form
PASTE
Route
TOPICAL
Labeler
Jeshurun Pharmaceutical LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-01
Substance
ZINC OXIDE; WHITE PETROLATUM; LANOLIN
Active strength
42.42; 139.629; 10.857 g/210g; g/210g; g/210g
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
Rash Buster
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE42.42 g/210g
WHITE PETROLATUM139.629 g/210g
LANOLIN10.857 g/210g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83347-1844-1Rash Buster210 g in 1 JARPASTE2106
83347-1844-2Rash Buster24 in 1 BOXPASTE246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83347-1844RASH BUSTER (ZINC OXIDE PASTE) PASTE [JESHURUN PHARMACEUTICAL LLC]5Current NDC, 2 package rows20250120_f771440f-0f6f-9ff7-e053-6294a90a10f3.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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMIDWOOD BRANDS, LLC.1d0eb8be-13b7-c466-e063-6294a90a93b92024-07-11WarningsExact identifier
application number: M016
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
application number: M016
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2635795lanolin 5.17 % / petrolatum 66.5 % / zinc oxide 20.2 % Topical PastePSNf771440f-0f6f-9ff7-e053-6294a90a10f36
2635795lanolin 0.0517 MG/MG / petrolatum 0.665 MG/MG / zinc oxide 0.202 MG/MG PasteSCDf771440f-0f6f-9ff7-e053-6294a90a10f36
2635795lanolin 0.0517 MG/MG / petrolatum 0.665 MG/MG / ZNO 0.202 MG/MG PasteSYf771440f-0f6f-9ff7-e053-6294a90a10f36
2635795lanolin 5.17 % / petrolatum 66.49 % / zinc oxide 20.2 % Topical PasteSYf771440f-0f6f-9ff7-e053-6294a90a10f36
2635795lanolin 5.17 % / petrolatum 66.5 % / zinc oxide 20.2 % Topical PasteSYf771440f-0f6f-9ff7-e053-6294a90a10f36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83347-1844-183347184401210 g in 1 JAR210 gHistorical
83347-1844-28334718440224 JAR in 1 BOX (83347-1844-2) / 210 g in 1 JAR (83347-1844-1) 24 jar2023-05-01NoNoCurrent