FDA.reportPublic FDA data

Remedy Skin Protectant

Product NDC
53329-302
11-digit product format
533290302
Labeler code
53329
Product ID
53329-302_efcfa488-6020-fcbd-e053-2995a90ad540
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
PASTE
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-06
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
59 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct53329-302DDiscontinued by firm2026-11-13
excluded packagepackage53329-30253329-302-14DDiscontinued by firm2026-11-13
excluded packagepackage53329-30253329-302-41DDiscontinued by firm2026-11-13

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 · 6 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 packagepackage53329-302-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-302-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-302-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-302-14f5e01cc5f278…a2eaf40c39c3…

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 INGREDIENT4T6H12BN9UREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
ALUMINUM STEARATESINACTIVE INGREDIENTO4D7U3B46UREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
PENTAERYTHRITYL DISTEARATEINACTIVE INGREDIENT697WOT8HNBREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZREMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-302REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES, LP]6Legacy NDC20241207_0ec52309-642f-4667-9199-6711190fa1d4.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 53 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
DoveMOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdebc5983-e8bc-c6d5-e053-2995a90af7742024-11-07WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREEConopco Inc. d/b/a/ Unileverdf734b51-33ae-d6b7-e053-2995a90a08cc2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdf73e518-caec-a73b-e053-2995a90a69f52024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER DEEP MOISTUREConopco Inc. d/b/a/ Unileverddca7c55-0a7e-cea6-e053-2995a90ace5a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unileverddcad36b-1909-3bbb-e053-2995a90a295a2024-11-07WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverddcbab1c-7af9-2656-e053-2995a90ad07a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENTConopco Inc. d/b/a/ Unileverdf74d901-c86c-ed71-e053-2995a90a39c22024-11-07WarningsExact identifier
application number: M016
Aveeno Baby Calming Comfort Bath Plus SetDIMETHICONEKenvue Brands LLC2c44fbc7-588f-41e2-953c-eebf24eecbf92024-11-06WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-302-145332903021457 g in 1 TUBE (53329-302-14) 57 g2013-11-060000-00-00NoNoCurrent
53329-302-4153329030241169.5 g in 1 TUBE (53329-302-41) 169.5 g2013-11-060000-00-00NoNoCurrent