OraLabs ChapIce Cherry SPF 4 Lip Balm

Product NDC
63645-111
11-digit product format
636450111
Labeler code
63645
Product ID
63645-111_33e3f014-ea35-4b27-b1cc-59fc0cff2caa
Type
HUMAN OTC DRUG
Nonproprietary name
Padimate O, Petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
OraLabs
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2000-01-03
Marketing end
0000-00-00
Substance
PADIMATE O; PETROLATUM
Active strength
15 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63645-111IInactivated by FDA2026-10-05
excluded packagepackage63645-11163645-111-01IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63645-111-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63645-111-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63645-111-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63645-111-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63645-111-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63645-111-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63645-111-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63645-111-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63645-111-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63645-111-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63645-111-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63645-111-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63645-111-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63645-111-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63645-111-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63645-111-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63645-111-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63645-111-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63645-111-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63645-111-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63645-111-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-111-012020-01-31C16284748780-19d75b9d1-0b04-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-111-01OraLabs ChapIce Cherry SPF 4 Lip Balm4.25 g in 1 CYLINDERSTICK4.251

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PADIMATE OACTIVE INGREDIENTZ11006CMUZORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
PADIMATE OACTIVE MOIETYZ11006CMUZORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
PETROLATUMACTIVE MOIETY4T6H12BN9UORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CERESININACTIVE INGREDIENTQ1LS2UJO3AORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
CHERRYINACTIVE INGREDIENTBUC5I9595WORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
LANOLININACTIVE INGREDIENT7EV65EAW6HORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-111ORALABS CHAPICE CHERRY SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [ORALABS]1Legacy NDC, 1 package rows20120912_33e3f014-ea35-4b27-b1cc-59fc0cff2caa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253140petrolatum 43.6 % Topical OintmentPSN33e3f014-ea35-4b27-b1cc-59fc0cff2caa1
253140petrolatum 0.436 MG/MG Topical OintmentSCD33e3f014-ea35-4b27-b1cc-59fc0cff2caa1
253140petrolatum 43.6 % Topical OintmentSY33e3f014-ea35-4b27-b1cc-59fc0cff2caa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63645-111-01636450111014.25 g in 1 CYLINDER4.25 gHistorical