FDA.reportPublic FDA data

Skin protectant

Product NDC
11344-247
11-digit product format
113440247
Labeler code
11344
Product ID
11344-247_5c1573ce-c2c0-4c37-e063-6394a90acb87
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-28
Substance
PETROLATUM
Active strength
410 mg/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
Skin protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM410 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-247-17Skin protectant50 g in 1 TUBEOINTMENT503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-247SKIN PROTECTANT (PETROLATUM) OINTMENT [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250213_22202a9c-f2ba-4c65-a493-bf3240f474e7.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Mercy Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.4bac19f3-13bb-8d18-e063-6394a90aa3932026-02-25WarningsExact identifier
application number: M016
Skin Mercy Intense Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.468f21c6-2d6f-1654-e063-6394a90ab2f52026-02-25WarningsExact identifier
application number: M016
Magnet Eye Sheet MaskEYE MASKGuangdong Bisutang Biotechnology Co., LTD4a0a84d4-4024-5ea7-e063-6394a90a2b6c2026-02-24WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEH E Bf0b31d52-2903-487a-aa70-0dbdf4c4d7e72026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEH E Ba8ad595a-c811-4534-82e0-9a01085b4b1e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALH E Bce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMeijer, Inc.12867b23-b203-4bd7-af6d-efddeead26be2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.c7a4b7f2-4de9-470c-9f5b-0142bd9351372026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMBetter Living Brands, LLC75cb8f17-6ef2-403e-ab6e-d8e1e8168ec82026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEBetter Living Brands, LLC1d491635-9605-44fa-9860-ea23e4e8b21c2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMBetter Living Brands, LLCba50f2b2-aff8-42cd-8af0-369060a901fb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
OatmealDIMETHICONEBetter Living Brands, LLCd28c5a60-0597-424f-bf7f-08dca39b22f52026-02-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725145petrolatum 41 % Topical OintmentPSN22202a9c-f2ba-4c65-a493-bf3240f474e73
725145petrolatum 0.41 MG/MG Topical OintmentSCD22202a9c-f2ba-4c65-a493-bf3240f474e73
725145petrolatum 41 % Topical OintmentSY22202a9c-f2ba-4c65-a493-bf3240f474e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-247-171134402471750 g in 1 TUBE (11344-247-17) 50 g2024-02-28NoNoCurrent