FDA.reportPublic FDA data

White Petrolatum

Product NDC
70000-0487
11-digit product format
700000487
Labeler code
70000
Product ID
70000-0487_5d2ea645-7892-5fd4-e063-6394a90a8f13
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-24
Substance
PETROLATUM
Active strength
1 g/g
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
White Petrolatum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-09-15CR-1147 White Petrolatum NDC 70000-0487-1
2020-09-15CR-1147 White Petrolatum NDC 70000-0487-1
2020-07-22CR-1147 White Petrolatum NDC 70000-0487-1
2020-07-22CR-1147 White Petrolatum NDC 70000-0487-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0487-1White Petrolatum12 in 1 CASEOINTMENT128
70000-0487-1White Petrolatum390 g in 1 JAROINTMENT3908
70000-0487-2White Petrolatum48 in 1 CASEOINTMENT487
70000-0487-2White Petrolatum71 g in 1 TUBEOINTMENT717
70000-0487-3White Petrolatum106 g in 1 JAROINTMENT1067
70000-0487-3White Petrolatum48 in 1 CASEOINTMENT487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0487-1GM - Gram70000-04872ead5d0b-54f5-4560-a440-c3ba40633d7312020-03-10
70000-0487-2GM - Gram70000-04877d54916c-a4d3-48e2-9e57-0a7524132f3e12021-11-09
70000-0487-3GM - Gram70000-04872a8cde1a-344e-4e56-a515-9e4ef62f73b212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0487WHITE PETROLATUM (SKIN PROTECTANT) OINTMENT [CARDINAL HEALTH]7Current NDC, Legacy NDC, 2 package rows20241127_8b381857-6f58-177e-e053-2995a90aa8c9.zip
70000-0487WHITE PETROLATUM (SKIN PROTECTANT) OINTMENT [CARDINAL HEALTH]6Current NDC, Legacy NDC, 4 package rows20241207_b9d033f3-4d14-a2c8-e053-2995a90ac7f1.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 1 MG/MG Topical OintmentSCD8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 100 % Topical JellySY8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 100 % Topical JellyPSNb9d033f3-4d14-a2c8-e053-2995a90ac7f17
204754petrolatum 1 MG/MG Topical OintmentSCDb9d033f3-4d14-a2c8-e053-2995a90ac7f17
204754petrolatum 100 % Topical JellySYb9d033f3-4d14-a2c8-e053-2995a90ac7f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0487-17000004870112 JAR in 1 CASE (70000-0487-1) / 390 g in 1 JAR12 jar2019-01-240000-00-00NoNoCurrent
70000-0487-27000004870248 TUBE in 1 CASE (70000-0487-2) / 71 g in 1 TUBE48 tube2021-03-150000-00-00NoNoCurrent
70000-0487-37000004870348 JAR in 1 CASE (70000-0487-3) / 106 g in 1 JAR48 jar2021-03-150000-00-00NoNoCurrent