FDA.reportPublic FDA data

Soothe and Cool Moisture Barrier

Product NDC
53329-071
11-digit product format
533290071
Labeler code
53329
Product ID
53329-071_e9b0b9fd-5057-7b6b-e053-2995a90a9d71
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-03-01
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
98 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-071DDiscontinued by firm2026-10-16
excluded packagepackage53329-07153329-071-14DDiscontinued by firm2026-10-16
excluded packagepackage53329-07153329-071-15DDiscontinued by firm2026-10-16
excluded packagepackage53329-07153329-071-16DDiscontinued by firm2026-10-16
excluded packagepackage53329-07153329-071-96DDiscontinued by firm2026-10-16

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage53329-071-14
excluded packagepackage53329-071-15
excluded packagepackage53329-071-16
excluded packagepackage53329-071-96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-071-142023-08-08071 Soothe & Cool Moisture Barrier Ointment
53329-071-152023-08-08071 Soothe & Cool Moisture Barrier Ointment
53329-071-162023-08-08071 Soothe & Cool Moisture Barrier Ointment
53329-071-962023-08-08071 Soothe & Cool Moisture Barrier Ointment
53329-071-142023-07-28071 Soothe & Cool Moisture Barrier Ointment
53329-071-152023-07-28071 Soothe & Cool Moisture Barrier Ointment
53329-071-162023-07-28071 Soothe & Cool Moisture Barrier Ointment
53329-071-962023-07-28071 Soothe & Cool Moisture Barrier Ointment

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-071-15GM - Gram53329-071ad0179fe-7181-45ac-92fb-67246b68165c12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9USOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9USOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
ALOEINACTIVE INGREDIENTV5VD430YW9SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMSOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-071SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]9Legacy NDC20241127_59625382-2769-4c91-9c53-e19dfd6ca115.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 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-071-145332900711456 g in 1 TUBE (53329-071-14) 56 g2019-01-010000-00-00NoNoCurrent
53329-071-1553329007115198 g in 1 TUBE (53329-071-15) 198 g2019-01-010000-00-00NoNoCurrent
53329-071-16533290071165 g in 1 PACKET (53329-071-16) 5 g2006-03-010000-00-00NoNoCurrent
53329-071-9653329007196144 PACKET in 1 BOX (53329-071-96) > 5 g in 1 PACKET (53329-071-16) 144 packet2006-03-010000-00-00NoNoCurrent