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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact 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