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 65 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.0ba98cdf-489e-dc2a-e063-6294a90adb382023-12-04WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.0baa8a14-8655-d77c-e063-6294a90ab8aa2023-12-04WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC86472a3d-7138-4141-8422-ab20c17a46e02023-12-04WarningsExact identifier
application number: M016
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
application number: M016
Manzatin-E Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.cafd084f-8493-4d6e-b256-2d4b4282f8662023-12-01WarningsExact identifier
application number: M016
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact 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