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 30 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health MedicatedWITCH HAZELCVS Pharmacya74ab253-cafc-4f00-9b8f-e5c1e6e7f2212025-12-05WarningsExact identifier
application number: M016
Major Medi-PadsWITCH HAZELMajor Pharmaceuticalsd2a314a2-98ab-4ac0-9e90-1a8c1303958f2025-12-05WarningsExact identifier
application number: M016
Good Sense MedicatedWITCH HAZELGeiss, Destin & Dunn, Inc5f122db5-4391-4957-9c25-76834c356c4f2025-12-05WarningsExact identifier
application number: M016
Witch HazelMEDICATED HEMORRHOIDAL WIPESGiant Eaglecdd9d6b7-cbc9-2839-e053-2a95a90ada002025-12-05WarningsExact identifier
application number: M016
Cool ComfortORGANIC WITCH HAZELNaticura Incde14c19c-56b5-4727-9194-94e85425ca8a2025-12-05WarningsExact identifier
application number: M016
GOODSENSE Maximum Strength MedicatedWITCH HAZELGEISS, DESTIN & DUNN, INC5453a12b-e775-4101-bd3a-337857e9e1672025-12-05WarningsExact identifier
application number: M016
Medicated Multipurpose WipesWITCH HAZELQUEST USA CORP.0f28d5f9-b20a-ac6f-e063-6394a90ac2082025-12-05WarningsExact identifier
application number: M016
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALGold Bond Co LLCc292e443-7418-4679-b9b2-4e6d96c04c4c2025-12-05WarningsExact identifier
application number: M016
Prequel Skin Utility OintMULTI PURPOSE SKIN PROTECTANTThe Center Brands, LLC2bf0931e-245d-14a6-e063-6294a90a66812025-12-04WarningsExact identifier
application number: M016
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant CreamCOLLOIDAL OATMEALGold Bond Co LLC8fbbfde8-ead1-434f-ae23-6e69662638e12025-12-04WarningsExact identifier
application number: M016
Gold Bond Diabetics Dry Skin Relief Foot CreamDIMETHICONE AND WHITE PETROLATUMGold Bond Co LLC77b8c30b-d5ba-42ce-9313-4ce1b0bce8732025-12-04WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALGold Bond Co LLCb96e5deb-f2c7-421b-afac-bffb1c9b37ac2025-12-04WarningsExact identifier
application number: M016
UNIVERSAL PURE PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC6bc34bbe-e324-48f4-b6df-dd508b19c2e22025-12-03WarningsExact identifier
application number: M016
Calming Itch and IrritationCOLLOIDAL OATMEALBetter Planet Brands LLC1dd7e712-56a4-86c0-e063-6294a90a75cd2025-12-03WarningsExact identifier
application number: M016
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
application number: M016
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 41%Twin Med LLC3d36e664-ac10-72eb-e063-6294a90a49c42025-12-01WarningsExact identifier
application number: M016
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
application number: M016
ESTRIOLESTRIOLShenzhen Mengyue Technology Co., Ltd.44de9eb4-080e-bfbc-e063-6394a90ac0ea2025-12-01WarningsExact 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