Lip Remedy Medicinal Lip Balm

Product NDC
75862-014
11-digit product format
758620014
Labeler code
75862
Product ID
75862-014_c0595792-471f-43c5-985b-8074f12a9c9f
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
STICK
Route
TOPICAL
Labeler
GANZ U.S.A., LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
32 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct75862-014IInactivated by FDA2026-10-05
excluded packagepackage75862-01475862-014-50IInactivated 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 · 44 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 packagepackage75862-014-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75862-014-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75862-014-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75862-014-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75862-014-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75862-014-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75862-014-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75862-014-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75862-014-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75862-014-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75862-014-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75862-014-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75862-014-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75862-014-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75862-014-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75862-014-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75862-014-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75862-014-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75862-014-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75862-014-50e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75862-014-509bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75862-014-50110d247fa046…a55b01930146…

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
75862-014-502019-10-29C16284748780-1960f7f55-c302-8e05-e053-dbdaa90a074atime & again ® LIP REMEDY medicinal lip balm with Menthol and Cocoa Seed Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75862-014-50Lip Remedy Medicinal Lip Balm RED4 g in 1 TUBESTICK41
75862-014-50Lip Remedy Medicinal Lip Balm RED1 in 1 BOXSTICK11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9ULIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
PETROLATUMACTIVE MOIETY4T6H12BN9ULIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ALIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
PHENOLINACTIVE INGREDIENT339NCG44TVLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1
SACCHARININACTIVE INGREDIENTFST467XS7DLIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75862-014LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]1Legacy NDC, 2 package rows20110222_0fe75852-2cb2-4d06-a2fe-56abbc8fe21e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110506petrolatum 32.3 % Medicated Lip BalmPSN0fe75852-2cb2-4d06-a2fe-56abbc8fe21e1
1110506petrolatum 0.323 MG/MG Topical OintmentSCD0fe75852-2cb2-4d06-a2fe-56abbc8fe21e1
1110506petrolatum 32.3 % Medicated Lip BalmSY0fe75852-2cb2-4d06-a2fe-56abbc8fe21e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
75862-014-50758620014504 g in 1 TUBE4 gHistorical