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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact 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