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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact 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