FDA.reportPublic FDA data

Chapstick Moisturizer Cool Mint

Product NDC
0573-0768
11-digit product format
005730768
Labeler code
0573
Product ID
0573-0768_4687328b-9343-4115-9a4b-21df2f93419d
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, and white petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
Substance
AVOBENZONE; OCTINOXATE; PETROLATUM
Active strength
30; 75; 414 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-511332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-121332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-391332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-39fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-51fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-40fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-3986f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-5186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-4086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-39bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-51bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-40bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-12bd6a592717d7…303034d00443…

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 Moisturizer Cool Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE75 mg/g
PETROLATUM414 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal 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
c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0573-0768-122024-03-21Drug Facts
0573-0768-392024-03-21Drug Facts
0573-0768-402024-03-21Drug Facts
0573-0768-512024-03-21Drug Facts
0573-0768-122022-01-28Drug Facts
0573-0768-392022-01-28Drug Facts
0573-0768-402022-01-28Drug Facts
0573-0768-512022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0768-12Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-12Chapstick Moisturizer Cool Mint1 in 1 BLISTER PACKSTICK14
0573-0768-39Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-39Chapstick Moisturizer Cool Mint3 in 1 BLISTER PACKSTICK34
0573-0768-40Chapstick Moisturizer Cool Mint3 in 1 BLISTER PACKSTICK34
0573-0768-40Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-51Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0768CHAPSTICK MOISTURIZER COOL MINT (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 7 package rows20240322_c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74.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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0768-12005730768121 CYLINDER in 1 BLISTER PACK (0573-0768-12) / 4 g in 1 CYLINDER1 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-39005730768393 CYLINDER in 1 BLISTER PACK (0573-0768-39) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-40005730768403 CYLINDER in 1 BLISTER PACK (0573-0768-40) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-51005730768514 g in 1 CYLINDER (0573-0768-51) 4 g2018-06-280000-00-00NoNoCurrent