FDA.reportPublic FDA data

Health Smart Lavender Baby Petroleum

Product NDC
52862-011
11-digit product format
528620011
Labeler code
52862
Product ID
52862-011_299e33ed-a5ce-78c7-e063-6294a90a10cf
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
99.9 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 · 11 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage52862-011-14
excluded packagepackage52862-011-19
excluded packagepackage52862-011-24
excluded packagepackage52862-011-20
excluded packagepackage52862-011-26
excluded packagepackage52862-011-25
excluded packagepackage52862-011-22
excluded packagepackage52862-011-21
excluded packagepackage52862-011-23
excluded packagepackage52862-011-01

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 Lavender Baby Petroleum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.9 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
1148414Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5828df37-2a42-4129-8e4e-d5ac9c4c9615Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52862-011-012020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-142020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-192020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-202020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-212020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-222020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-232020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-242020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-252020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-262020-08-115828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-012020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-142020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-192020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-202020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-212020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-222020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-232020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-242020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-252020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615
52862-011-262020-01-315828df37-2a42-4129-8e4e-d5ac9c4c9615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-011-01Health Smart Lavender Baby Petroleum226 g in 1 BOTTLEJELLY2264
52862-011-14Health Smart Lavender Baby Petroleum113 g in 1 BOTTLEJELLY1134
52862-011-19Health Smart Lavender Baby Petroleum50 g in 1 BOTTLEJELLY504
52862-011-20Health Smart Lavender Baby Petroleum100 g in 1 BOTTLEJELLY1004
52862-011-21Health Smart Lavender Baby Petroleum170 g in 1 BOTTLEJELLY1704
52862-011-22Health Smart Lavender Baby Petroleum283 g in 1 BOTTLEJELLY2834
52862-011-23Health Smart Lavender Baby Petroleum368 g in 1 BOTTLEJELLY3684
52862-011-24Health Smart Lavender Baby Petroleum425 g in 1 BOTTLEJELLY4254
52862-011-25Health Smart Lavender Baby Petroleum450 g in 1 BOTTLEJELLY4504
52862-011-26Health Smart Lavender Baby Petroleum500 g in 1 BOTTLEJELLY5004

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-011HEALTH SMART LAVENDER BABY PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]4Current NDC, Legacy NDC, 10 package rows20241222_5828df37-2a42-4129-8e4e-d5ac9c4c9615.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 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema ReliefOATMEALCOSMETIQUE ACTIVE PRODUCTIONe555de17-9b42-4125-a17b-467bc1d179d72023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing ReliefOATMEALL'Oreal USA Products Incf7b71606-0044-4729-82e8-4514331806a02023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSN5828df37-2a42-4129-8e4e-d5ac9c4c96154
1148414petrolatum 0.999 MG/MG Topical GelSCD5828df37-2a42-4129-8e4e-d5ac9c4c96154
1148414petrolatum 99.9 % Topical JellySY5828df37-2a42-4129-8e4e-d5ac9c4c96154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-011-0152862001101226 g in 1 BOTTLE (52862-011-01) 226 g2013-07-280000-00-00NoNoCurrent
52862-011-1452862001114113 g in 1 BOTTLE (52862-011-14) 113 g2013-07-280000-00-00NoNoCurrent
52862-011-195286200111950 g in 1 BOTTLE (52862-011-19) 50 g2013-07-280000-00-00NoNoCurrent
52862-011-2052862001120100 g in 1 BOTTLE (52862-011-20) 100 g2013-07-280000-00-00NoNoCurrent
52862-011-2152862001121170 g in 1 BOTTLE (52862-011-21) 170 g2013-07-280000-00-00NoNoCurrent
52862-011-2252862001122283 g in 1 BOTTLE (52862-011-22) 283 g2013-07-280000-00-00NoNoCurrent
52862-011-2352862001123368 g in 1 BOTTLE (52862-011-23) 368 g2013-07-280000-00-00NoNoCurrent
52862-011-2452862001124425 g in 1 BOTTLE (52862-011-24) 425 g2013-07-280000-00-00NoNoCurrent
52862-011-2552862001125450 g in 1 BOTTLE (52862-011-25) 450 g2013-07-280000-00-00NoNoCurrent
52862-011-2652862001126500 g in 1 BOTTLE (52862-011-26) 500 g2013-07-280000-00-00NoNoCurrent