FDA.reportPublic FDA data

Petroleum

Product NDC
63868-601
11-digit product format
638680601
Labeler code
63868
Product ID
63868-601_43ce6f90-a81f-1189-e063-6294a90a48cd
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Marketing end
2027-09-30
Substance
PETROLATUM
Active strength
100 g/100g
NDC exclude flag
No
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
Petroleum

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM100 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
684ac03a-f9b1-412d-8ce5-819ca132dc34Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-601-04Petroleum113 g in 1 JARJELLY1134
63868-601-13Petroleum368 g in 1 JARJELLY3684

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-601-04GM - Gram63868-6017e7c628b-1685-4592-9aa1-1e35f1bd8f7512022-09-12
63868-601-13GM - Gram63868-601d70be96c-d09a-4c60-ad1c-eecc034fbdfc12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-601PETROLEUM (WHITE PETROLATUM) JELLY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20241220_684ac03a-f9b1-412d-8ce5-819ca132dc34.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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
application number: M003
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN684ac03a-f9b1-412d-8ce5-819ca132dc344
204754petrolatum 1 MG/MG Topical OintmentSCD684ac03a-f9b1-412d-8ce5-819ca132dc344
204754petrolatum 100 % Topical JellySY684ac03a-f9b1-412d-8ce5-819ca132dc344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-601-0463868060104113 g in 1 JAR (63868-601-04) 113 g2020-01-012027-09-30NoNoCurrent
63868-601-1363868060113368 g in 1 JAR (63868-601-13) 368 g2020-01-012027-03-31NoNoCurrent