Petroleum Skin Protectant

Product NDC
11344-069
11-digit product format
113440069
Labeler code
11344
Product ID
11344-069_5b88db78-8cf8-9282-e063-6394a90a08d9
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11344-06911344-069-10DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Petroleum Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-069-10Petroleum Skin Protectant28.3 g in 1 TUBEJELLY28.318
11344-069-27Petroleum Skin Protectant369 g in 1 JARJELLY36918
11344-069-54Petroleum Skin Protectant106 g in 1 JARJELLY10618
11344-069-96Petroleum Skin Protectant213 g in 1 JARJELLY21318

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [VI-JON]1
PETROLATUMACTIVE MOIETY4T6H12BN9UPETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [VI-JON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-069PETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [CONSUMER PRODUCT PARTNERS, LLC]17Current NDC, Legacy NDC, 4 package rows20250205_0b1a09b8-6499-4f41-836a-ad839c63f74f.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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD Laser BalmPETROLATUM SKIN PROTECTANTCP Skin Health Group, Inc1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb2023-11-09WarningsExact identifier
application number: M016
DiaperDerm Diaper RashZINC OXIDEDiaperderm Inc4e1fce3e-c2b7-42da-9953-1dbb13e2467c2023-11-06WarningsExact identifier
application number: M016
Doctors Diaper Rash CreamZINC OXIDEDOCTOR'S DIAPER RASH CREAM, INC0988ccb1-7881-4d97-bcbf-d0cf4316e4be2023-11-06WarningsExact identifier
application number: M016
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
application number: M016
GL HEALTH Barrier Skin ProtectantZINC OXIDEGL HEALTH, INC.76cfa330-fea9-48d4-b187-469154765d392023-11-06WarningsExact identifier
application number: M016
Skin-lubePETROLATUM, DIMETHICONEThe Hygenic Company, LLC.d1005dec-04f6-3f88-e053-2a95a90ad9cb2023-11-05WarningsExact identifier
application number: M016
Dr. Sheffield Anti Itch CreamANTI ITCH CREAMSheffield Pharmaceuticals LLC77f0593e-f694-4c02-9fd9-ad56ff2a920c2023-10-30WarningsExact identifier
application number: M016
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN0b1a09b8-6499-4f41-836a-ad839c63f74f18
204754petrolatum 1 MG/MG Topical OintmentSCD0b1a09b8-6499-4f41-836a-ad839c63f74f18
204754petrolatum 100 % Topical JellySY0b1a09b8-6499-4f41-836a-ad839c63f74f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11344-069-101134400691028.3 g in 1 JAR (11344-069-10) 28.3 g1989-07-150000-00-00NoNoCurrent
11344-069-2711344006927369 g in 1 JAR (11344-069-27) 369 g1989-07-150000-00-00NoNoCurrent
11344-069-5411344006954106 g in 1 JAR (11344-069-54) 106 g1989-07-150000-00-00NoNoCurrent
11344-069-9611344006996213 g in 1 JAR (11344-069-96) 213 g1989-07-150000-00-00NoNoCurrent