FDA.reportPublic FDA data

Health Smart Original Petroleum

Product NDC
52862-013
Requested package NDC
52862-013-01
11-digit product format
528620013
Labeler code
52862
Product ID
52862-013_299b291d-b1dc-cb52-e063-6394a90a439f
Type
HUMAN OTC DRUG
Nonproprietary name
White Petroleum
Dosage form
JELLY
Route
TOPICAL
Labeler
Home Smart Products
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-28
Substance
PETROLATUM
Active strength
100 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52862-01352862-013-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
Health Smart Original Petroleum
Listing expiration
2027-12-31

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
aedf746f-4c49-421d-a666-1ba02e8fb17dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52862-013-012020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-142020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-192020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-202020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-212020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-222020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-232020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-242020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-252020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-262020-08-11aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-012020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-142020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-192020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-202020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-212020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-222020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-232020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-242020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-252020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d
52862-013-262020-01-31aedf746f-4c49-421d-a666-1ba02e8fb17d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-013-01Health Smart Original Petroleum226 g in 1 BOTTLEJELLY2265
52862-013-14Health Smart Original Petroleum113 g in 1 BOTTLEJELLY1135
52862-013-19Health Smart Original Petroleum50 g in 1 BOTTLEJELLY505
52862-013-20Health Smart Original Petroleum100 g in 1 BOTTLEJELLY1005
52862-013-21Health Smart Original Petroleum170 g in 1 BOTTLEJELLY1705
52862-013-22Health Smart Original Petroleum283 g in 1 BOTTLEJELLY2835
52862-013-23Health Smart Original Petroleum368 g in 1 BOTTLEJELLY3685
52862-013-24Health Smart Original Petroleum425 g in 1 BOTTLEJELLY4255
52862-013-25Health Smart Original Petroleum450 g in 1 BOTTLEJELLY4505
52862-013-26Health Smart Original Petroleum500 g in 1 BOTTLEJELLY5005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UHEALTH SMART ORIGINAL PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]1
PETROLATUMACTIVE MOIETY4T6H12BN9UHEALTH SMART ORIGINAL PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-013HEALTH SMART ORIGINAL PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]5Current NDC, Legacy NDC, 10 package rows20241222_aedf746f-4c49-421d-a666-1ba02e8fb17d.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 63 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact identifier
application number: M016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNaedf746f-4c49-421d-a666-1ba02e8fb17d5
204754petrolatum 1 MG/MG Topical OintmentSCDaedf746f-4c49-421d-a666-1ba02e8fb17d5
204754petrolatum 100 % Topical JellySYaedf746f-4c49-421d-a666-1ba02e8fb17d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-013-0152862001301226 g in 1 BOTTLE (52862-013-01) 226 g2013-07-280000-00-00NoNoCurrent