FDA.reportPublic FDA data

Chapstick

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:57

Label at a glance#

ProductChapstick 12 Days of Christmas
Active ingredientPETROLATUM
Label structure4 sections

Label contents#

Full prescribing information#

Classic Original | Cherry

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 45%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Other Information

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Inactive ingredients (Classic Original)

INACTIVE INGREDIENT SECTION

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

Inactive ingredients (Classic Cherry)

INACTIVE INGREDIENT SECTION

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Questions or Comments?

OTC - QUESTIONS SECTION

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

Cosmetic Lip Balms

SPL UNCLASSIFIED SECTION

Ingredients (Clover Honey)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, canola oil, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, synthetic wax, iron oxides, isopropyl titanium triisostearate

Ingredients (Cake Batter)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, phenyl trimethicone, arachidyl propionate, beeswax, isopropyl myristate, copernicia cerifera (carnauba) wax, lecithin (soy), cetyl alcohol, flavor, triacetin, benzyl benzoate, saccharin, titanium dioxide, synthetic wax, isopropyl titanium triisostearate

Ingredients (Cotton Candy)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, benzyl benzoate, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, synthetic wax, blue 1 lake, isopropyl titanium triisostearate

Ingredients (Passion Fruit)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, canola oil, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, flavor, cetyl alcohol, lecithin (soy), saccharin, synthetic wax, iron oxides, yellow 6 lake, isopropyl titanium triisostearate

Ingredients (Holiday Cocoa)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, synthetic wax, yellow 5 lake, blue 1 lake, isopropyl titanium triisostearate

Ingredients (Vanilla Latte)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, phenyl trimethicone, arachidyl propionate, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, flavor, titanium dioxide, synthetic wax, saccharin, triacetin, iron

oxides, isopropyl titanium triisostearate

Ingredients (Pumpkin Pie)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, isopropyl myristate, flavor, cetyl alcohol, lecithin (soy), triacetin, synthetic wax, saccharin, iron oxides, titanium dioxide, yellow 6 lake, isopropyl titanium triisostearate

Ingredients (Candy Cane)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, flavor, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, titanium dioxide, synthetic wax, saccharin, canola oil, isopropyl titanium triisostearate

Ingredients (Vanilla Mint)

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, flavor, cetyl alcohol, lecithin (soy), ethyl alcohol, saccharin

Other Information

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Additional Information

SPL UNCLASSIFIED SECTION

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.chapstick.com

Trademarks owned or licensed by GSK

©2021 GSK or licensor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2028-01

12 days of

ChapStick ®

to

from

  • 1 Classic Original Skin Protectant
  • 1 Classic Cherry Skin Protectant
  • 10 Cosmetic Lip Balms

12 STICKS

NET WT 0.15 OZ

(4 g) EACH

000065947 – Front

Chapstick 12 Days of Christmas 12 ct
Chapstick 12 Days of Christmas 12 ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-2029-012023-02-04C16284748780-1f386c649-e42e-0266-e053-dadaa90a7c1aDrug Facts
0135-2029-012023-01-30C16284748780-1f386c649-e42e-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-2029-01Chapstick12 Days of Christmas1 in 1 PACKAGEKIT13
0573-0701-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK4 g450 mg in 1g3
0573-0701-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0705-12Chapstick12 Days of Christmas1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0705-12Chapstick12 Days of Christmas4 g in 1 CYLINDERSTICK4 g450 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-2029CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 5 package rows20240413_040694f0-b5ba-4203-bde9-699fa9b1afef.zip
0573-0701CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240413_040694f0-b5ba-4203-bde9-699fa9b1afef.zip
0573-0705CHAPSTICK 12 DAYS OF CHRISTMAS (WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240413_040694f0-b5ba-4203-bde9-699fa9b1afef.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
0573-0705-12GM - Gram0573-0705f57c711a-4a41-407f-a88f-bdea0a19da2512022-12-07

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-20290135-2029-01
0573-07010573-0701-12
0573-07050573-0705-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
LEVOMENTHOLBZ1R15MTK7IACT
OCTYLDODECANOL461N1O614YIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
D&C RED NO. 6481744AI4OIACT
SACCHARINFST467XS7DIACT
WHITE WAX7G1J5DA97FIACT
PETROLATUM4T6H12BN9UACTIB

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 · 6 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): 0573-0705-12
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
ndc11 (package): 00573070512
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): 0135-2029-01
ndc (package): 0573-0705-12
ndc (package): 0573-0701-12
ndc (product): 0135-2029
ndc11 (package): 00573070112
ndc11 (package): 00573070512
ndc11 (package): 00135202901
spl id: 15d67c46-c55d-6f63-e063-6294a90a55dd
spl set id: 040694f0-b5ba-4203-bde9-699fa9b1afef
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
ndc (package): 0573-0705-12
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
ndc11 (package): 00573070512
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
ndc (package): 0573-0705-12
ndc (product): 0573-0705
ndc11 (package): 00573070512
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
ndc (package): 0573-0701-12
ndc (product): 0573-0701
ndc11 (package): 00573070112

Reported adverse events (FAERS/openFDA)#

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