ODEUR Senior Premium Cleanser

Product NDC
69798-001
11-digit product format
697980001
Labeler code
69798
Product ID
69798-001_563cf998-d5c1-4128-b32b-679db590e839
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
SJ Bio Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-05-11
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
1 g/632.19g
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 productproduct69798-001IInactivated by FDA2026-10-16
excluded packagepackage69798-00169798-001-02IInactivated by FDA2026-10-16

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69798-001-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69798-001-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69798-001-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69798-001-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69798-001-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69798-001-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69798-001-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69798-001-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69798-001-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69798-001-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69798-001-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69798-001-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69798-001-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69798-001-022025-01-07C16284748780-19d75b9d0-455e-f424-e053-dadaa90a57ceDrug Facts
69798-001-022020-01-31C16284748780-19d75b9d0-455e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69798-001-01ODEUR Senior Premium Cleanser632.19 g in 1 BOTTLEGEL632.194
69798-001-02ODEUR Senior Premium Cleanser1 in 1 CARTONGEL14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
MENTHOLACTIVE MOIETYL7T10EIP3AODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
AMINOCAPROIC ACIDINACTIVE INGREDIENTU6F3787206ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
ARTEMISIA VULGARIS ROOTINACTIVE INGREDIENT32MP823R8SODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXIODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
BAMBUSA VULGARIS TOPINACTIVE INGREDIENTFIW80T6P6VODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
CAPRYL/CAPRAMIDOPROPYL BETAINEINACTIVE INGREDIENT231H3ZT9NEODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
CRATAEGUS LAEVIGATA FLOWERINACTIVE INGREDIENT85EAT04F4HODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
HEXANEDIOLINACTIVE INGREDIENTZIA319275IODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
HIPPOPHAE RHAMNOIDES FRUITINACTIVE INGREDIENTAVL0R9111TODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI233ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
MATRICARIA RECUTITA FLOWERING TOPINACTIVE INGREDIENT3VNC7T6Z02ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
MUNG BEANINACTIVE INGREDIENT1LIB31N73GODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
PEG-60 CASTOR OILINACTIVE INGREDIENTVXP26NM2XXODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
POLYQUATERNIUM-10 (400 MPA.S AT 2%)INACTIVE INGREDIENTHB1401PQFSODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
RHEUM PALMATUM ROOTINACTIVE INGREDIENTG025DAL7CEODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
RICE BRANINACTIVE INGREDIENTR60QEP13ICODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
SODIUM COCOAMPHOACETATEINACTIVE INGREDIENTW7Q5E87674ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
TURMERICINACTIVE INGREDIENT856YO1Z64FODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69798-001ODEUR SENIOR PREMIUM CLEANSER (MENTHOL) GEL [SJ BIO CO., LTD.]4Legacy NDC, 2 package rows20250109_fa2348d2-77d9-4c44-b24c-82de4c1e4278.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69798-001-0169798000101632.19 g in 1 BOTTLE632.19 gHistorical
69798-001-02697980001021 in 1 CARTONHistorical