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 46 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
application number: M016
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
application number: M016
AOAO Retinol Anti-aging Box SetCOLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.Guangdong Junhui Biotechnology Co., LTD24fdc31b-5291-a649-e063-6394a90a9c652025-01-08WarningsExact identifier
application number: M016
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
application number: M016
TURMERICFaceCreamNIACINAMIDEShengnan (Guangzhou) Cosmetics Co., LTD2b0652be-a216-d66b-e063-6394a90a0b282025-01-06WarningsExact identifier
application number: M016
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
application number: M016
ClearSoothingCreamHYALURONIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD2ac88f9a-a41b-1978-e063-6394a90a24212025-01-03WarningsExact identifier
application number: M016
MILKBODyLotionUREAShengnan (Guangzhou) Cosmetics Co., LTD2ac99028-a811-9332-e063-6294a90aee5c2025-01-03WarningsExact identifier
application number: M016
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
application number: M016
Badger DiaperZINC OXIDEW.S. Badger Company, Inc.674542b2-33fb-4664-857d-4ff1d7f768a02024-12-31WarningsExact identifier
application number: M016
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
application number: M016
SkinCeuticals Advanced Scar Control Skin ProtectantALLANTOINL'Oreal USA Products Inc83f4bfbb-47d8-4fe9-ba33-85142ec6221c2024-12-28WarningsExact identifier
application number: M016
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDEZINC OXIDEBentley Laboratories, LLCa35ae585-f899-4c7e-8cd2-c0b2fe6a20782024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact 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