FDA.reportPublic FDA data

Chapstick

Product NDC
0573-0804
11-digit product format
005730804
Labeler code
0573
Product ID
0573-0804_15d3f64f-90e0-c56e-e063-6294a90a8c45
Type
HUMAN OTC DRUG
Nonproprietary name
white petrolatum
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-01
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
Brand name suffix
12 Days of Christmas
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
d6eb2ea6-27c7-40a6-a1f0-789ea2131de3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0701-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g2
0573-0701-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK1 g450 mg in 1g2
0573-0715-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK1 g450 mg in 1g2
0573-0715-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g2
0573-0804-01Chapstick12 Days of Christmas1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0804CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]2Current NDC, 5 package rows20240413_d6eb2ea6-27c7-40a6-a1f0-789ea2131de3.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 12 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doue Pure petroleum OriginalPETROLATUMONEST LIMITED57188500-fccf-4348-af4f-cf22324cf29e2026-05-01WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
application number: M016
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-0701-12005730701121 in 1 BLISTER PACKHistorical
0573-0715-12005730715124 g in 1 CYLINDER4 gHistorical
0573-0804-01005730804011 KIT in 1 PACKAGE (0573-0804-01) * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0715-12) / 4 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0701-12) / 4 g in 1 CYLINDER1 kit2023-09-01NoNoCurrent