FDA.reportPublic FDA data

Chapstick

Product NDC
0573-2027
11-digit product format
005732027
Labeler code
0573
Product ID
0573-2027_17672368-32db-9bca-e063-6394a90a7c62
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, and white petrolatum
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-28
NDC exclude flag
No
Listing certified through
2026-12-31
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
Chapstick
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e34fc74-772e-48fd-a353-58807ef412c1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2027-012023-02-04C16284748780-1f386c649-d476-0266-e053-dadaa90a7c1aDrug Facts
0573-2027-012023-01-30C16284748780-1f386c649-d476-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0701-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0701-12Chapstick4 g in 1 CYLINDERSTICK12 g450 mg in 1g3
0573-0705-12Chapstick4 g in 1 CYLINDERSTICK12 g450 mg in 1g3
0573-0705-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0715-12Chapstick4 g in 1 CYLINDERSTICK8 g450 mg in 1g3
0573-0715-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0725-12Chapstick4 g in 1 CYLINDERSTICK8 g423 mg in 1g3
0573-0725-12Chapstick1 in 1 BLISTER PACKSTICK75 mg in 1g3
0573-2027-01Chapstick1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2027CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 9 package rows20240502_0e34fc74-772e-48fd-a353-58807ef412c1.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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMIDWOOD BRANDS, LLC.1d0eb8be-13b7-c466-e063-6294a90a93b92024-07-11WarningsExact identifier
application number: M016
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
application number: M016
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0701-12005730701121 in 1 BLISTER PACKHistorical
0573-0705-12005730705124 g in 1 CYLINDER4 gHistorical
0573-0715-12005730715124 g in 1 CYLINDER4 gHistorical
0573-0725-12005730725124 g in 1 CYLINDER4 gHistorical
0573-2027-01005732027011 KIT in 1 PACKAGE (0573-2027-01) * 1 CYLINDER in 1 BLISTER PACK (0573-0705-12) / 4 g in 1 CYLINDER * 3.5 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0701-12) / 4 g in 1 CYLINDER * 3.5 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0715-12) / 4 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0725-12) / 4 g in 1 CYLINDER1 kit2021-04-280000-00-00NoNoCurrent