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 16 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
application number: M003
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.531cea18-9609-4d78-876d-3ba5d2d1e16f2026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.b0d302c2-58a0-4c3e-9c4a-fd34de40c0342026-06-15Warnings, Adverse reactionsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEWildman Business Group1fd15b91-6b81-d0bd-e063-6294a90a4d272026-06-15WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.540bde3c-5af2-456a-e063-6294a90aa7742026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fall Scents-AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a09b6-2928-9fbf-e063-6394a90a3c4d2026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-Spiced CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a41cf-5c63-c6fc-e063-6294a90abfcc2026-06-12WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a8aa9-1d4b-28ec-e063-6294a90aa34e2026-06-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5211ec31-90bc-e0fc-e063-6294a90a76ed2026-06-11WarningsExact identifier
application number: M003
Smart Care Squishmallows Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f5d658-dd1a-bb8e-e063-6294a90adbb12026-06-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fall Scents-Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f6c000-849b-0045-e063-6294a90aa2f12026-06-11WarningsExact identifier
application number: M003
EVR Alcohol Prep PadsLSOPROPYL ALCOHOLJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD5406ba2f-6729-b9e7-e063-6394a90ac5532026-06-11WarningsExact identifier
application number: M003
MISTIFY FROSTY CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e4f854-750b-7322-e063-6294a90a11102026-06-10WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.53ea8cec-bf36-4eec-e063-6394a90a559c2026-06-10WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLCVS PHARMACY, INCb30468f6-7a1b-4165-916f-36df21eb10e52026-06-09WarningsExact identifier
application number: M003
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Marketing Association34062b23-52aa-99ae-e063-6294a90ae73f2026-06-09WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Marketing Association2419c9f9-3e15-4d0e-b422-a6110281fd1d2026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53dd3d76-81c9-ed6b-e063-6394a90aaea32026-06-09WarningsExact 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