FDA.reportPublic FDA data

ChapStick Classic Original

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:01

Label at a glance#

ProductChapStick Classic Original
Active ingredientPETROLATUM
Label structure9 sections

Storage and handling

Other Information store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

White Petrolatum 45%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center away.

DOSAGE & ADMINISTRATION SECTION

Directions

apply as needed

STORAGE AND HANDLING SECTION

Other Information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium dioxide, white wax, yellow 5 lake

OTC - QUESTIONS SECTION

Questions or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

Additional information

SPL UNCLASSIFIED SECTION

Marketed by: Pfizer

Madison, NJ 07940 USA

©2017 Pfizer Inc.

For most recent product information,

Visit www.chapstick.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BRAND LIP CARE
ChapStick ®
SKIN PROTECTANT

CLASSIC
ORIGINAL

PROTECTS AND MOISTURIZES TO
HELP HEAL DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0701-122023-03-20C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-302023-03-20C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-402023-03-20C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-512023-03-20C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-122022-01-28C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-302022-01-28C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-402022-01-28C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts
0573-0701-512022-01-28C16284748780-1d6a99b39-e603-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0701-12ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-12ChapStick Classic Original1 in 1 BLISTER PACKSTICK14
0573-0701-30ChapStick Classic Original3 in 1 BLISTER PACKSTICK34
0573-0701-30ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-40ChapStick Classic Original4 g in 1 CYLINDERSTICK44
0573-0701-40ChapStick Classic Original3 in 1 BLISTER PACKSTICK34
0573-0701-51ChapStick Classic Original4 g in 1 CYLINDERSTICK44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0701CHAPSTICK CLASSIC ORIGINAL (WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 7 package rows20240321_42fe0f4a-efb7-4e70-a359-db7dc2ac9905.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0701-51GM - Gram0573-07011e39ab2a-7df8-4022-9cb8-f71b01cc969412022-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-07010573-0701-12, 0573-0701-30, 0573-0701-40, 0573-0701-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
OCTYLDODECANOL461N1O614YIACT
OLEYL ALCOHOL172F2WN8DVIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
D&C RED NO. 6481744AI4OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WHITE WAX7G1J5DA97FIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
ndc (package): 0573-0701-40
ndc (package): 0573-0701-30
ndc (package): 0573-0701-51
ndc (package): 0573-0701-12
ndc (product): 0573-0701
ndc11 (package): 00573070140
ndc11 (package): 00573070151
ndc11 (package): 00573070112
ndc11 (package): 00573070130
spl id: dfb149cd-ff79-4a68-82eb-0ba6e2cb542c
spl set id: 42fe0f4a-efb7-4e70-a359-db7dc2ac9905

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.