FDA.reportPublic FDA data

Medline

Product NDC
53329-186
11-digit product format
533290186
Labeler code
53329
Product ID
53329-186_42c7c6aa-dac4-0498-e063-6394a90a3516
Type
HUMAN OTC DRUG
Nonproprietary name
petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
Substance
WHITE PETROLATUM
Active strength
934 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM934 mg/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
2601369Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3062b61-e4c4-9f57-e053-2995a90aa028Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-186-14Medline1 in 1 BOXOINTMENT14
53329-186-14Medline56.6 g in 1 TUBEOINTMENT56.64
53329-186-16Medline5 g in 1 PACKETOINTMENT54
53329-186-96Medline144 in 1 BOXOINTMENT1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-186MEDLINE (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]3Current NDC, 4 package rows20241207_f3062b61-e4c4-9f57-e053-2995a90aa028.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 54 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unilevered234413-777a-9c82-e053-2a95a90a6f982024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceCATCHING THE SUNRISE HAND SANITIZERConopco Inc. d/b/a/ Unileverb9fa6c72-7c56-6fd0-e053-2995a90a67072024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASHConopco Inc. d/b/a/ Unilevered24b320-27fc-9714-e053-2995a90a79a62024-11-07WarningsExact identifier
application number: M016
SKINSEIETHYL ALCOHOL LIQUIDConopco Inc. d/b/a/ Unilevera603c419-238f-0bae-e053-2a95a90abc2b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceUNDER THE STARLIT SKY HAND SANITIZERConopco Inc. d/b/a/ Unileverba0dfe52-c550-94fd-e053-2995a90a98002024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUMMERTIME SPRINKLERS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0e474c-db62-910f-e053-2995a90a889e2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceGIRLS NIGHT OUT HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ce03e-5e7b-b09a-e053-2995a90a4eef2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceAFTER THE RAIN HAND SANITIZERConopco Inc. d/b/a/ Unileverba0d27fb-f72f-5e87-e053-2a95a90af7e02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CATCUS FLOWER AND BASIL HAND SANITIZERConopco Inc. d/b/a/ Unileverba47599c-3e11-cec3-e053-2a95a90aef7b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceWRAPPED IN YOUR ARMS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ef938-da18-3b9c-e053-2995a90acb722024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUNKISSED OCEAN WAVES HAND SANITIZERConopco Inc. d/b/a/ Unileverba0db6a3-222a-093f-e053-2a95a90ac88a2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceLAZY WEEKENDS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0f4571-e752-d925-e053-2995a90afd3a2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZERConopco Inc. d/b/a/ Unileverba48b351-0d7f-5a41-e053-2a95a90a348c2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED COCONUT AND WARM VANILLA HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ffbf9-7dd0-f685-e053-2995a90a0be02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZERConopco Inc. d/b/a/ Unileverba49e27b-1ade-a75a-e053-2a95a90a18432024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZERConopco Inc. d/b/a/ Unileverba4979a3-ae30-42e4-e053-2995a90abfe72024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSWEET TREATS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0fa3cb-8c25-7511-e053-2995a90a42872024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED LAVENDER AND HYSSOP HAND SANITIZERConopco Inc. d/b/a/ Unileverba484531-ef7b-17ed-e053-2995a90a50b32024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZERConopco Inc. d/b/a/ Unileverba4a573d-def4-a735-e053-2995a90a4f292024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unileverddcb0871-9903-125f-e053-2a95a90a75de2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601369petrolatum 93.4 % Topical OintmentPSNf3062b61-e4c4-9f57-e053-2995a90aa0284
2601369petrolatum 0.934 MG/MG Topical OintmentSCDf3062b61-e4c4-9f57-e053-2995a90aa0284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-186-14533290186141 TUBE in 1 BOX (53329-186-14) / 56.6 g in 1 TUBE1 tube2023-04-01NoNoCurrent
53329-186-16533290186165 g in 1 PACKET (53329-186-16) 5 g2023-04-01NoNoCurrent
53329-186-9653329018696144 PACKET in 1 BOX (53329-186-96) / 5 g in 1 PACKET (53329-186-16) 144 packet2023-04-01NoNoCurrent