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 16 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Eczema ReliefCOLLOIDAL OATMEALOld East Main Co.b2dba027-c295-4a41-8d30-144904e1aa342026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEChain Drug Marketing Association1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6932026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact 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