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 57 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Daily MoisturizingDIMETHICONETARGET CORPORATIONf118e0eb-1e66-50ab-e053-2995a90a2cb92024-10-14WarningsExact identifier
application number: M016
Target Up and Up Petroleum JellyWHITE PETROLATUMTARGET CORPORATIONbaeaf660-ac4f-1ebc-e053-2995a90ac0c12024-10-14WarningsExact identifier
application number: M016
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
application number: M016
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
application number: M016
Attitude Diaper Cream Zinc UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)00283894-ddc6-0faa-e063-6394a90ae47c2024-10-02WarningsExact identifier
application number: M016
DermacinRx Zinc Oxide Skin HealingZINC OXIDEPureTek Corporation541b8da8-f0c1-4f57-94a7-193084d9a6112024-10-02WarningsExact identifier
application number: M016
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
application number: M016
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
application number: M016
Barrier Build Skin Protectant CreamCOLLOIDAL OATMEALILIA, Inc.231d41b8-2a56-6eb8-e063-6394a90ac64f2024-09-27WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.229ee3a7-4129-7b59-e063-6394a90a6f402024-09-23WarningsExact identifier
application number: M016
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

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