FDA.reportPublic FDA data

Chapstick

Product NDC
0573-0804
Requested package NDC
0573-0804-01
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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
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