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 firm2026-10-21
excluded packagepackage53329-30353329-303-22DDiscontinued by firm2026-10-21

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 58 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact identifier
application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Frag FreePETROLATUMMeijer Distribution0a0e6de8-b7c1-af7e-e063-6394a90a3ee22024-08-26WarningsExact identifier
application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Fresh ScentPETROLATUMMeijer Distribution0a0e9b39-9ce1-e788-e063-6294a90abf0b2024-08-26WarningsExact identifier
application number: M016
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
application number: M016
BioBarrier Repair Eye CreamALLANTOINBluemercury Inc.1ee70a3c-76cc-335f-e063-6294a90a4f492024-08-04WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEDabur India Ltd1e6143c1-cd08-c171-e063-6394a90a2cee2024-07-29WarningsExact identifier
application number: M016
HealthWise Petroleum JellyWHITE PETROLATUMVeridian Healthcare1e189d97-2677-e8d7-e063-6394a90ac3d62024-07-25WarningsExact 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