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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact 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