FDA.reportPublic FDA data

CHAPSTICK CLASSIC MEDICATED

Product NDC
0573-2031
11-digit product format
005732031
Labeler code
0573
Product ID
0573-2031_0fa3bc9f-6381-a321-e063-6394a90a470e
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-15
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM
Active strength
16; 6; 410 mg/g; mg/g; mg/g
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 CLASSIC MEDICATED
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)16 mg/g
MENTHOL, UNSPECIFIED FORM6 mg/g
PETROLATUM410 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
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
b4259621-ff41-46cc-a658-b57bff3c1525Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2031-01CHAPSTICK CLASSIC MEDICATED4 g in 1 CYLINDERSTICK43
0573-2031-01CHAPSTICK CLASSIC MEDICATED1 in 1 BLISTER PACKSTICK13
0573-2031-02CHAPSTICK CLASSIC MEDICATED4 g in 1 CYLINDERSTICK43
0573-2031-02CHAPSTICK CLASSIC MEDICATED2 in 1 BLISTER PACKSTICK23
0573-2031-03CHAPSTICK CLASSIC MEDICATED12 in 1 PACKAGESTICK123
0573-2031-03CHAPSTICK CLASSIC MEDICATED4 g in 1 CYLINDERSTICK43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2031CHAPSTICK CLASSIC MEDICATED (CAMPHOR, MENTHOL, PETROLATUM) STICK [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 6 package rows20240124_b4259621-ff41-46cc-a658-b57bff3c1525.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 25 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water Drench Hyaluronic Healing BalmDIMETHICONEPeter Thomas Roth Labs, LLC3f789176-1d80-d146-e063-6294a90a948a2026-01-13WarningsExact identifier
application number: M016
DERMEDIAL Anti-ItchOATMEAL, ZINC OXIDESaje Natural Business Inc385dd757-740b-8324-e063-6294a90afeee2026-01-13WarningsExact identifier
application number: M016
Sweet cheeksZINC OXIDESaje Natural Business Inc.5fc6486e-8604-5c7b-e053-2991aa0a8d142026-01-13WarningsExact identifier
application number: M016
TeevodarALLANTOINPEER PHARM LTD.57a1b6d1-9439-462b-aeb9-ef806e572eaf2026-01-12WarningsExact identifier
application number: M016
Botao Baby Diaper Rash CreamZINC OXIDEPeer Pharm Ltd.df60a70e-e6c0-41b3-e053-2995a90af1762026-01-12WarningsExact identifier
application number: M016
ECZEMA HAND RELIEFCOLLOIDAL OATMEALSkinfix, Inc.0389bab7-04fb-7cfc-e063-6394a90a22d82026-01-12WarningsExact identifier
application number: M016
SKINFIX HAND REPAIROATMEALSkinfix, Inc.1b65fc81-1b9e-4260-829a-332cf6891d022026-01-12WarningsExact identifier
application number: M016
ECZEMA INTENSIVE DAILY RELIEF BODYCOLLOIDAL OATMEAL CREAMSkinfix, Inc.0be3c631-bc9b-00a9-e063-6394a90abcbb2026-01-12WarningsExact identifier
application number: M016
SarnaCOLLOIDAL OATMEALCrown Laboratories, Inc.2d6b1872-9f4d-9eb3-e063-6394a90ab6752026-01-12WarningsExact identifier
application number: M016
XIMONTH Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.47f1a711-5d6f-c023-e063-6294a90aa8012026-01-09WarningsExact identifier
application number: M016
Endit zinc oxide skin protectionZINC OXIDEEndIt Laboratories, Inc.e60bb0da-3349-f8f9-e053-2a95a90a90512026-01-09WarningsExact identifier
application number: M016
Endit Zinc Oxide Skin ProtectantZINC OXIDEEndit Laboratories, Inc.55b3aa07-871d-421b-b76a-c2d359d6003f2026-01-09WarningsExact identifier
application number: M016
Flanders ButtocksWHITE PETROLATUM, ZINC OXIDEFlanders Inc32371159-c76d-41b0-e054-00144ff88e882026-01-09WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC47da77ea-ab4e-fc3c-e063-6394a90a27b72026-01-08WarningsExact identifier
application number: M016
Z-BumDIAPER RASH CREAMGM Pharmaceuticals, Inc2a36f396-3a30-3f3f-e054-00144ff8d46c2026-01-08WarningsExact identifier
application number: M016
Daily VLotionDIMETHICONEKindra1cc4b804-6483-68fd-e063-6294a90a38e42026-01-08WarningsExact identifier
application number: M016
V Relief SerumDIMETHICONEKindra1cd8a9e9-ac88-1799-e063-6294a90a32782026-01-08WarningsExact identifier
application number: M016
DR SMITHS DIAPERZINC OXIDEMission Pharmacal7705b182-acf7-4195-9996-7d9fcdfbf0552026-01-08WarningsExact identifier
application number: M016
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2031-01005732031011 CYLINDER in 1 BLISTER PACK (0573-2031-01) / 4 g in 1 CYLINDER1 cylinder2022-03-150000-00-00NoNoCurrent
0573-2031-02005732031022 CYLINDER in 1 BLISTER PACK (0573-2031-02) / 4 g in 1 CYLINDER2 cylinder2022-03-150000-00-00NoNoCurrent
0573-2031-030057320310312 CYLINDER in 1 PACKAGE (0573-2031-03) / 4 g in 1 CYLINDER12 cylinder2022-03-150000-00-00NoNoCurrent