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 67 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
application number: M003
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer My Little PonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e45fe7d-b30c-9273-e063-6294a90ae8e12025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer Peppa pigALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e466475-351f-614e-e063-6394a90ab25a2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e46fe11-247f-36ad-e063-6294a90a1dd42025-09-08WarningsExact identifier
application number: M003
Green Guard Super Stat Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation47355df2-de67-4cf9-b367-645228e494ce2025-09-08WarningsExact identifier
application number: M003
Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation2e544963-aa49-49cd-837e-9d89d86e257f2025-09-08WarningsExact identifier
application number: M003
Medi-first Protective Coating BandageBENZETHONIUM CHLORIDE AND BENZOCAINEUnifirst First Aid Corporation05b0aef9-1553-4e95-8798-f41e5999bb462025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporation3f7fb451-e701-4aa8-814e-ceeb5c2198d92025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Alcohol Wipes70% ISOPROPYL ALCOHOLUnifirst First Aid Corporation3f507990-282a-4b26-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Green Guard Sterile Alcohol WipesISOPROPYL ALCOHOL 70%Unifirst First Aid Corporation570baa70-e519-328b-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporation5743634b-f329-5fec-e053-2991aa0a751d2025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniFirst First Aid Corporation1bdd57c3-cdaf-a085-e063-6394a90a1e3d2025-09-08WarningsExact 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