Soothe and Cool Moisture Guard

Product NDC
53329-303
11-digit product format
533290303
Labeler code
53329
Product ID
53329-303_efd0f6f1-820d-32e8-e053-2a95a90a0e66
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-303DDiscontinued by firm2026-10-20
excluded packagepackage53329-30353329-303-22DDiscontinued by firm2026-10-20

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 · 4 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 packagepackage53329-303-22d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-303-22f5e01cc5f278…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 INGREDIENT4T6H12BN9USOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
PETROLATUMACTIVE MOIETY4T6H12BN9USOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
ALUMINUM STEARATESINACTIVE INGREDIENTO4D7U3B46USOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744SOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41SOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
CORN OILINACTIVE INGREDIENT8470G57WFMSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZESOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
PENTAERYTHRITYL DISTEARATEINACTIVE INGREDIENT697WOT8HNBSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-303SOOTHE AND COOL MOISTURE GUARD (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES, LP]7Legacy NDC20230715_4577a053-3837-412f-a784-ed86a7cccc59.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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-303-225332903032299 g in 1 TUBE (53329-303-22) 99 g2013-11-060000-00-00NoNoCurrent