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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Arthcal Bioidentical Peach CreamARTHCAL BIOIDENTICAL PEACH CREAMBeijing JUNGE Technology Co., Ltd.3c77f787-b7dd-6813-e063-6394a90aa0042025-08-16Boxed warning, WarningsExact identifier
application number: M016
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
application number: M016
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
application number: M016
AmeriDerm PeriShieldZINC OXIDEShield Line LLC417f1541-d65a-4612-b96b-e6183fbef1f32025-08-15WarningsExact identifier
application number: M016
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact 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