FDA.reportPublic FDA data

White Petrolatum

Product NDC
70000-0487
11-digit product format
700000487
Labeler code
70000
Product ID
70000-0487_5d2ea645-7892-5fd4-e063-6394a90a8f13
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-24
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
White Petrolatum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-09-15CR-1147 White Petrolatum NDC 70000-0487-1
2020-09-15CR-1147 White Petrolatum NDC 70000-0487-1
2020-07-22CR-1147 White Petrolatum NDC 70000-0487-1
2020-07-22CR-1147 White Petrolatum NDC 70000-0487-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0487-1White Petrolatum12 in 1 CASEOINTMENT128
70000-0487-1White Petrolatum390 g in 1 JAROINTMENT3908
70000-0487-2White Petrolatum48 in 1 CASEOINTMENT487
70000-0487-2White Petrolatum71 g in 1 TUBEOINTMENT717
70000-0487-3White Petrolatum106 g in 1 JAROINTMENT1067
70000-0487-3White Petrolatum48 in 1 CASEOINTMENT487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0487-1GM - Gram70000-04872ead5d0b-54f5-4560-a440-c3ba40633d7312020-03-10
70000-0487-2GM - Gram70000-04877d54916c-a4d3-48e2-9e57-0a7524132f3e12021-11-09
70000-0487-3GM - Gram70000-04872a8cde1a-344e-4e56-a515-9e4ef62f73b212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0487WHITE PETROLATUM (SKIN PROTECTANT) OINTMENT [CARDINAL HEALTH]7Current NDC, Legacy NDC, 2 package rows20241127_8b381857-6f58-177e-e053-2995a90aa8c9.zip
70000-0487WHITE PETROLATUM (SKIN PROTECTANT) OINTMENT [CARDINAL HEALTH]6Current NDC, Legacy NDC, 4 package rows20241207_b9d033f3-4d14-a2c8-e053-2995a90ac7f1.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 1 MG/MG Topical OintmentSCD8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 100 % Topical JellySY8b381857-6f58-177e-e053-2995a90aa8c98
204754petrolatum 100 % Topical JellyPSNb9d033f3-4d14-a2c8-e053-2995a90ac7f17
204754petrolatum 1 MG/MG Topical OintmentSCDb9d033f3-4d14-a2c8-e053-2995a90ac7f17
204754petrolatum 100 % Topical JellySYb9d033f3-4d14-a2c8-e053-2995a90ac7f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0487-17000004870112 JAR in 1 CASE (70000-0487-1) / 390 g in 1 JAR12 jar2019-01-240000-00-00NoNoCurrent
70000-0487-27000004870248 TUBE in 1 CASE (70000-0487-2) / 71 g in 1 TUBE48 tube2021-03-150000-00-00NoNoCurrent
70000-0487-37000004870348 JAR in 1 CASE (70000-0487-3) / 106 g in 1 JAR48 jar2021-03-150000-00-00NoNoCurrent