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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact 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