FDA.reportPublic FDA data

ChapStick Classic Original

Product NDC
0573-0701
11-digit product format
005730701
Labeler code
0573
Product ID
0573-0701_dfb149cd-ff79-4a68-82eb-0ba6e2cb542c
Type
HUMAN OTC DRUG
Nonproprietary name
white petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-28
Substance
PETROLATUM
Active strength
450 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0701-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0701-12fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0701-40fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0701-51fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0701-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0701-1286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0701-4086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0701-5186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0701-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0701-12bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0701-40bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0701-51bd6a592717d7…303034d00443…

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
ChapStick Classic Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM450 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42fe0f4a-efb7-4e70-a359-db7dc2ac9905Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0573-0701-122023-03-20Drug Facts
0573-0701-302023-03-20Drug Facts
0573-0701-402023-03-20Drug Facts
0573-0701-512023-03-20Drug Facts
0573-0701-122022-01-28Drug Facts
0573-0701-302022-01-28Drug Facts
0573-0701-402022-01-28Drug Facts
0573-0701-512022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0701-12ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-12ChapStick Classic Original1 in 1 BLISTER PACKSTICK14
0573-0701-30ChapStick Classic Original3 in 1 BLISTER PACKSTICK34
0573-0701-30ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-40ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-40ChapStick Classic Original3 in 1 BLISTER PACKSTICK34
0573-0701-51ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0701-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK4 g450 mg in 1g3
0573-0701-12Chapstick4 g in 1 CYLINDERSTICK12 g450 mg in 1g3
0573-0701-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0701-12Chapstick Holiday Classics Kit4 g in 1 CYLINDERSTICK8 g450 mg in 1g2
0573-0701-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g2
0573-0701-12Chapstick Holiday Classics Kit1 in 1 BLISTER PACKSTICK450 mg in 1g2
0573-0701-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK1 g450 mg in 1g2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0701-51GM - Gram0573-07011e39ab2a-7df8-4022-9cb8-f71b01cc969412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0701CHAPSTICK CLASSIC ORIGINAL (WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 7 package rows20240321_42fe0f4a-efb7-4e70-a359-db7dc2ac9905.zip
0573-0701CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip
0573-0701CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240413_040694f0-b5ba-4203-bde9-699fa9b1afef.zip
0573-0701CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC20240413_d6eb2ea6-27c7-40a6-a1f0-789ea2131de3.zip
0573-0701CHAPSTICK HOLIDAY CLASSICS KIT (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC20240413_6df216dc-c03d-463a-8029-5e54c1dc3d27.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0701-12005730701121 CYLINDER in 1 BLISTER PACK (0573-0701-12) / 4 g in 1 CYLINDER1 cylinder2018-06-280000-00-00NoNoCurrent
0573-0701-30005730701303 CYLINDER in 1 BLISTER PACK (0573-0701-30) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0701-40005730701403 CYLINDER in 1 BLISTER PACK (0573-0701-40) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0701-51005730701514 g in 1 CYLINDER (0573-0701-51) 4 g2018-06-280000-00-00NoNoCurrent