FDA.reportPublic FDA data

WHITE PETROLATUM

Product NDC
68786-211
11-digit product format
687860211
Labeler code
68786
Product ID
68786-211_4b822859-4163-d637-e063-6294a90af8f8
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
JELLY
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-16
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

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
53ca3aeb-1d5d-4964-adb5-1cfa901642daAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-211-01WHITE PETROLATUM144 in 1 BOXJELLY14417
68786-211-01WHITE PETROLATUM6 in 1 CASEJELLY617
68786-211-02WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-02WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-03WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-03WHITE PETROLATUM28.35 g in 1 TUBEJELLY28.3517
68786-211-04WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-04WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-05WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-05WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-06WHITE PETROLATUM92 g in 1 TUBEJELLY9217
68786-211-06WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-07WHITE PETROLATUM12 in 1 BOXJELLY1217
68786-211-07WHITE PETROLATUM6 in 1 CASEJELLY617
68786-211-08WHITE PETROLATUM113 g in 1 TUBEJELLY11317
68786-211-08WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-09WHITE PETROLATUM12 in 1 CASEJELLY1217
68786-211-09WHITE PETROLATUM425 g in 1 JARJELLY42517
68786-211-10WHITE PETROLATUM284 g in 1 TUBEJELLY28417
68786-211-10WHITE PETROLATUM24 in 1 CASEJELLY2417
68786-211-11WHITE PETROLATUM144 in 1 CASEJELLY14417
68786-211-11WHITE PETROLATUM28 g in 1 TUBEJELLY2817

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68786-211-01GM - Gram68786-211c6752c4b-4bfc-4e35-b89c-3735dd9285d312023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UWHITE PETROLATUM (PETROLATUM) JELLY [SION BIOTEXT MEDICAL LTD]7
PETROLATUMACTIVE MOIETY4T6H12BN9UWHITE PETROLATUM (PETROLATUM) JELLY [SION BIOTEXT MEDICAL LTD]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-211WHITE PETROLATUM (PETROLATUM) JELLY [SION BIOTEXT MEDICAL LTD]15Current NDC, Legacy NDC, 22 package rows20241218_53ca3aeb-1d5d-4964-adb5-1cfa901642da.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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN53ca3aeb-1d5d-4964-adb5-1cfa901642da17
204754petrolatum 1 MG/MG Topical OintmentSCD53ca3aeb-1d5d-4964-adb5-1cfa901642da17
204754petrolatum 100 % Topical JellySY53ca3aeb-1d5d-4964-adb5-1cfa901642da17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-211-01687860211016 BOX in 1 CASE (68786-211-01) / 144 PACKET in 1 BOX / 5 g in 1 PACKET6 box2014-02-160000-00-00NoNoCurrent
68786-211-026878602110272 BOX in 1 CASE (68786-211-02) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE72 box2014-02-160000-00-00NoNoCurrent
68786-211-0368786021103100 TUBE in 1 CASE (68786-211-03) / 28.35 g in 1 TUBE100 tube2014-02-160000-00-00NoNoCurrent
68786-211-046878602110472 BOX in 1 CASE (68786-211-04) / 1 TUBE in 1 BOX / 56.7 g in 1 TUBE72 box2014-02-160000-00-00NoNoCurrent
68786-211-056878602110572 BOX in 1 CASE (68786-211-05) / 1 TUBE in 1 BOX / 92 g in 1 TUBE72 box2014-02-160000-00-00NoNoCurrent
68786-211-0668786021106100 TUBE in 1 CASE (68786-211-06) / 92 g in 1 TUBE100 tube2014-02-160000-00-00NoNoCurrent
68786-211-07687860211076 BOX in 1 CASE (68786-211-07) / 12 TUBE in 1 BOX / 113 g in 1 TUBE6 box2014-02-160000-00-00NoNoCurrent
68786-211-0868786021108100 TUBE in 1 CASE (68786-211-08) / 113 g in 1 TUBE100 tube2014-02-160000-00-00NoNoCurrent
68786-211-096878602110912 JAR in 1 CASE (68786-211-09) / 425 g in 1 JAR12 jar2014-02-160000-00-00NoNoCurrent
68786-211-106878602111024 TUBE in 1 CASE (68786-211-10) / 284 g in 1 TUBE24 tube2014-02-160000-00-00NoNoCurrent
68786-211-1168786021111144 TUBE in 1 CASE (68786-211-11) / 28 g in 1 TUBE144 tube2024-12-05NoNoCurrent