SHINMO SAENGBALEUM TREATMENT

Product NDC
69978-002
11-digit product format
699780002
Labeler code
69978
Product ID
69978-002_a3d9b832-0e66-417c-80e2-c14dae83123c
Type
HUMAN OTC DRUG
Nonproprietary name
PANTHENOL
Dosage form
GEL
Route
TOPICAL
Labeler
ATEC&CO INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-07-20
Marketing end
0000-00-00
Substance
PANTHENOL
Active strength
1 g/958.5g
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 productproduct69978-002IInactivated by FDA2026-08-17
excluded packagepackage69978-00269978-002-02IInactivated by FDA2026-08-17

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69978-002-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69978-002-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69978-002-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69978-002-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69978-002-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69978-002-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69978-002-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69978-002-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69978-002-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02IInactivated 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 packagepackage69978-002-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69978-002-022020-01-31C16284748780-19d75b9d0-f6f7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69978-002-01SHINMO SAENGBALEUM TREATMENT958.50 g in 1 BOTTLEGEL958.503
69978-002-02SHINMO SAENGBALEUM TREATMENT1 in 1 CARTONGEL13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTHENOLACTIVE INGREDIENTWV9CM0O67ZSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
PANTHENOLACTIVE MOIETYWV9CM0O67ZSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ACORUS GRAMINEUS ROOTINACTIVE INGREDIENTZ60N6Q6E19SHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ACTAEA DAHURICA ROOTINACTIVE INGREDIENT1D114JZ36BSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ANGELICA DAHURICA ROOTINACTIVE INGREDIENT1V63N2S972SHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ANGELICA GIGAS ROOTINACTIVE INGREDIENT32766B2FHXSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ARTEMISIA PRINCEPS LEAFINACTIVE INGREDIENTSY077EW02GSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXISHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
ATRACTYLODES LANCEA ROOTINACTIVE INGREDIENTCAZ6282J2OSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
BETAINEINACTIVE INGREDIENT3SCV180C9WSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
BLETILLA STRIATA BULBINACTIVE INGREDIENT00T5SH6SEJSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CARAMELINACTIVE INGREDIENTT9D99G2B1RSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BASHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
FALLOPIA MULTIFLORA ROOTINACTIVE INGREDIENTAUZ3VD75MCSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
JOJOBA OILINACTIVE INGREDIENT724GKU717MSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
MYRISTYL ALCOHOLINACTIVE INGREDIENTV42034O9PUSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
PANTHENYL ETHYL ETHERINACTIVE INGREDIENTF4WMF8NX3BSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
PLATYCLADUS ORIENTALIS LEAFINACTIVE INGREDIENT32E5V7G32BSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
POLYQUATERNIUM-10 (400 MPA.S AT 2%)INACTIVE INGREDIENTHB1401PQFSSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
PUNICA GRANATUM ROOT BARKINACTIVE INGREDIENTCLV24I3T1DSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
PURSLANEINACTIVE INGREDIENTM6S840WXG5SHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
RHEUM PALMATUM ROOTINACTIVE INGREDIENTG025DAL7CESHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
RICE GERMINACTIVE INGREDIENT7N2B70SFEZSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SAFFLOWERINACTIVE INGREDIENT4VBL71TY4YSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SAPOSHNIKOVIA DIVARICATA ROOTINACTIVE INGREDIENT8H84LFK2QDSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SESAME SEEDINACTIVE INGREDIENT7Y1255HVXRSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SOPHORA FLAVESCENS ROOTINACTIVE INGREDIENTIYR6K8KQ5KSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
STEARAMIDOPROPYL DIMETHYLAMINEINACTIVE INGREDIENTK7VEI00UFRSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
TRIDECETH-10INACTIVE INGREDIENTG624N6MSBASHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69978-002SHINMO SAENGBALEUM TREATMENT (PANTHENOL) GEL [ATEC&CO INC.]3Legacy NDC, 2 package rows20150720_431a3c93-5b41-41c1-acd3-b4e5645434ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69978-002-0169978000201958.50 g in 1 BOTTLE958.50 gHistorical
69978-002-02699780002021 in 1 CARTONHistorical