Advanced Petrolatum

Product NDC
42213-042
11-digit product format
422130042
Labeler code
42213
Product ID
42213-042_f0fe66ff-926b-5b2a-e053-2995a90a90c4
Type
HUMAN OTC DRUG
Nonproprietary name
petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ultra Seal Corporation
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-05
Marketing end
2023-05-31
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42213-042DDiscontinued by firm2026-10-15
excluded packagepackage42213-04242213-042-28DDiscontinued by firm2026-10-15
excluded packagepackage42213-04242213-042-80DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42213-042-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42213-042-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42213-042-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42213-042-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42213-042-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42213-042-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42213-042-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42213-042-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42213-042-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42213-042-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42213-042-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42213-042-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42213-042-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42213-042-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42213-042-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42213-042-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42213-042-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42213-042-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42213-042-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42213-042-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42213-042-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42213-042-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42213-042-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42213-042-80557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UADVANCED PETROLATUM (PETROLATUM) OINTMENT [ULTRA SEAL CORPORATION]1
PETROLATUMACTIVE MOIETY4T6H12BN9UADVANCED PETROLATUM (PETROLATUM) OINTMENT [ULTRA SEAL CORPORATION]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UADVANCED PETROLATUM (PETROLATUM) OINTMENT [ULTRA SEAL CORPORATION]1

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 45 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aluroderm ScarALLANTOINOlakino Therapeutics LLC2a848dde-8fc4-ab10-e063-6294a90a25832025-02-07WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijerc79352e9-d9a3-0d42-e053-2a95a90a5ea22025-02-06WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELFamily Dollar (FAMILY WELLNESS)a2047ef3-cda4-4411-a4c2-d7fb03f5b0692025-02-06WarningsExact identifier
application number: M016
First honey Burn SalveALLANTOINFirst Honey, LLCf40a9a34-1827-7171-e053-2a95a90acf312025-02-04WarningsExact identifier
application number: M016
Manuka Honey Extra StrengthALLANTOINFirst Honey LLCb742585d-9a0c-489b-b268-590583cfabd12025-02-04WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELCardinal Health (Leader) 7000036deb7de-14b0-44a4-89bb-51cc1770e65b2025-02-04WarningsExact identifier
application number: M016
NIVAGEN ZINC OXIDEZINC OXIDENivagen Pharmaceuticals, Inc.7b42655b-2163-4637-9f5d-1d2efa1bdf1d2025-02-03WarningsExact identifier
application number: M016
MATYS Baby ECZEMA RELIEFCOLLOIDAL OATMEALMatys Healthy Products LLC4c052bed-0931-4b8d-b033-b1872272c5982025-01-29WarningsExact identifier
application number: M016
MATYS Baby DIAPER RASH RELIEFZINC OXIDEMatys Healthy Products LLCf214db72-bf4f-46d7-8ffc-6333185a69d52025-01-29WarningsExact identifier
application number: M016
EARLY MOMMY Baby Bum ButtaZINC OXIDETEKT TONE LABS LLC4bd417ba-3d24-46e3-a771-3183824f02192025-01-28WarningsExact identifier
application number: M016
Rite Aid ScarALLANTOIN 0.5%Rite Aidfd152c8f-6df5-1236-e053-6394a90a865d2025-01-27WarningsExact identifier
application number: M016
BIA Eczema ReliefOATMEALCodex Labs Corporation2f2de819-b7db-4c1e-9d6e-9ce33f7e6d052025-01-27WarningsExact identifier
application number: M016
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
application number: M016
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
application number: M016
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
application number: M016
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
application number: M016
Baby XtraCare OatmealDIMETHICONERejoice International0049462b-ff31-440f-9244-b61153625bca2025-01-23WarningsExact identifier
application number: M016
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
application number: M016
Bebe BottomsZINC OXIDETARO PHARMACEUTICALS U.S.A., INC.eb8512db-f8a9-432c-8779-2971411ce43d2025-01-21WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLC2c2337cf-4507-7232-e063-6294a90a79c32025-01-20WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42213-042-284221300422828 g in 1 TUBE (42213-042-28) 28 g2011-04-050000-00-00NoNoCurrent
42213-042-8042213004280144 PACKET in 1 BOX (42213-042-80) > 5 g in 1 PACKET (42213-042-05) 144 packet2011-04-050000-00-00NoNoCurrent