FDA.reportPublic FDA data

White Petrolatum

Product NDC
67777-005
11-digit product format
677770005
Labeler code
67777
Product ID
67777-005_4ddba886-ec28-ef1e-e063-6394a90a3a86
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-26
Substance
WHITE 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
WHITE PETROLATUM1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81f5092d-0632-bf47-e053-2991aa0ac563Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-005-00White Petrolatum6 in 1 CASEOINTMENT616
67777-005-01White Petrolatum5 g in 1 PACKETOINTMENT516
67777-005-01White Petrolatum144 in 1 BOXOINTMENT14416
67777-005-10White Petrolatum72 in 1 CASEOINTMENT7216
67777-005-11White Petrolatum28.4 g in 1 TUBEOINTMENT28.416
67777-005-11White Petrolatum1 in 1 BOXOINTMENT116
67777-005-50White Petrolatum12 in 1 CASEOINTMENT1216
67777-005-51White Petrolatum6 in 1 BOXOINTMENT616
67777-005-52White Petrolatum113 g in 1 TUBEOINTMENT11316
67777-005-70White Petrolatum12 in 1 CASEOINTMENT1216
67777-005-71White Petrolatum425 g in 1 JAROINTMENT42516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-005-00GM - Gram67777-0051e703ffb-25e0-4539-a55b-ae79cc33a97612023-02-06
67777-005-01GM - Gram67777-005fcf3f885-1a7b-4752-ae06-5940b03c1dea12023-02-06
67777-005-10GM - Gram67777-005f48da0d1-d196-40ca-a7d3-1f968876770312025-08-11
67777-005-11GM - Gram67777-0053e904469-b9cf-40a0-a01f-26863c21a48f12025-08-11
67777-005-50GM - Gram67777-005eee594e2-a87c-4b52-89bc-b661e4124a6912025-08-11
67777-005-51GM - Gram67777-005a2ecce11-c67d-46d4-bfa7-5e46739163a412025-08-11
67777-005-52GM - Gram67777-005b0b2903a-0369-494a-a452-e18ba127960512026-02-05
67777-005-70GM - Gram67777-005023727a0-bd8e-4ebc-b2e2-cebeacf1415c12023-02-06
67777-005-71GM - Gram67777-005ef89ae89-c21f-4148-abf8-4cad09966eb512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-005WHITE PETROLATUM (PETROLATUM) OINTMENT [DYNAREX CORPORATION]10Current NDC, Legacy NDC, 11 package rows20240131_81f5092d-0632-bf47-e053-2991aa0ac563.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 JellyPSN81f5092d-0632-bf47-e053-2991aa0ac56316
204754petrolatum 1 MG/MG Topical OintmentSCD81f5092d-0632-bf47-e053-2991aa0ac56316
204754petrolatum 100 % Topical JellySY81f5092d-0632-bf47-e053-2991aa0ac56316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-005-00677770005006 BOX in 1 CASE (67777-005-00) / 144 PACKET in 1 BOX (67777-005-01) / 5 g in 1 PACKET6 box2018-10-260000-00-00NoNoCurrent
67777-005-01677770005015 g in 1 PACKET5 gHistorical
67777-005-106777700051072 BOX in 1 CASE (67777-005-10) / 1 TUBE in 1 BOX (67777-005-11) / 28.4 g in 1 TUBE72 box2018-10-260000-00-00NoNoCurrent
67777-005-116777700051128.4 g in 1 TUBE28.4 gHistorical
67777-005-506777700055012 BOX in 1 CASE (67777-005-50) / 6 TUBE in 1 BOX (67777-005-51) / 113 g in 1 TUBE (67777-005-52) 12 box2018-10-260000-00-00NoNoCurrent
67777-005-51677770005516 TUBE in 1 BOX (67777-005-51) / 113 g in 1 TUBE (67777-005-52) 6 tube2018-10-26NoNoCurrent
67777-005-5267777000552113 g in 1 TUBE113 gHistorical
67777-005-706777700057012 JAR in 1 CASE (67777-005-70) / 425 g in 1 JAR (67777-005-71) 12 jar2018-10-260000-00-00NoNoCurrent
67777-005-7167777000571425 g in 1 JAR425 gHistorical