FDA.reportPublic FDA data

cold hot patch

Product NDC
57900-002
11-digit product format
579000002
Labeler code
57900
Product ID
57900-002_9fc97756-8b39-4e37-85f1-bffdc6d3334c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Zhejiang Bangli Medical Products CO.,LTD
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-03-18
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57900-002-012019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-022019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-032019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-042019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-052019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-062019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-072019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-082019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-092019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-102019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-112019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch
57900-002-122019-11-27C16284748780-19855e2a2-3570-60a7-e053-dbdaa90a05bdcold& hot patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57900-002-01cold hot patch12 in 1 PACKAGEPATCH121
57900-002-01cold hot patch4 in 1 CARTONPATCH41
57900-002-02cold hot patch3 in 1 CARTONPATCH31
57900-002-02cold hot patch12 in 1 PACKAGEPATCH121
57900-002-03cold hot patch4 in 1 CARTONPATCH41
57900-002-03cold hot patch12 in 1 PACKAGEPATCH121
57900-002-04cold hot patch1 in 1 BOXPATCH11
57900-002-04cold hot patch50 in 1 CARTONPATCH501
57900-002-05cold hot patch48 in 1 CARTONPATCH481
57900-002-05cold hot patch3 in 1 BOXPATCH31
57900-002-06cold hot patch8 in 1 CARTONPATCH81
57900-002-06cold hot patch6 in 1 PACKAGEPATCH61
57900-002-07cold hot patch4 in 1 CARTONPATCH41
57900-002-07cold hot patch6 in 1 PACKAGEPATCH61
57900-002-08cold hot patch50 in 1 PACKAGEPATCH501
57900-002-08cold hot patch4 in 1 CARTONPATCH41
57900-002-09cold hot patch30 in 1 CARTONPATCH301
57900-002-09cold hot patch1 in 1 BOXPATCH11
57900-002-10cold hot patch8 in 1 CARTONPATCH81
57900-002-10cold hot patch6 in 1 PACKAGEPATCH61
57900-002-11cold hot patch6 in 1 PACKAGEPATCH61
57900-002-11cold hot patch4 in 1 CARTONPATCH41
57900-002-12cold hot patch6 in 1 PACKAGEPATCH61
57900-002-12cold hot patch8 in 1 CARTONPATCH81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XGCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Acrylic AcidINACTIVE INGREDIENTJ94PBK7X8SCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN0COLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Methyl AcrylateINACTIVE INGREDIENTWC487PR91HCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188COLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
POLYACRYLIC ACID (8000 MW)INACTIVE INGREDIENT73861X4K5FCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Sorbitan SesquioleateINACTIVE INGREDIENT0W8RRI5W5ACOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Tartaric AcidINACTIVE INGREDIENTW4888I119HCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1
WaterINACTIVE INGREDIENT059QF0KO0RCOLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57900-002COLD HOT PATCH (MENTHOL) PATCH [ZHEJIANG BANGLI MEDICAL PRODUCTS CO.,LTD]1Legacy NDC, 24 package rows20140319_4c1dbeae-29fc-445d-bd7a-d2141f29fb76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN4c1dbeae-29fc-445d-bd7a-d2141f29fb761
420222menthol 0.05 MG/MG Medicated PatchSCD4c1dbeae-29fc-445d-bd7a-d2141f29fb761
420222menthol 5 % Medicated PatchSY4c1dbeae-29fc-445d-bd7a-d2141f29fb761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57900-002-015790000020112 in 1 PACKAGEHistorical
57900-002-02579000002023 in 1 CARTONHistorical
57900-002-03579000002034 in 1 CARTONHistorical
57900-002-04579000002041 in 1 BOXHistorical
57900-002-055790000020548 in 1 CARTONHistorical
57900-002-06579000002068 in 1 CARTONHistorical
57900-002-07579000002074 in 1 CARTONHistorical
57900-002-085790000020850 in 1 PACKAGEHistorical
57900-002-095790000020930 in 1 CARTONHistorical
57900-002-10579000002108 in 1 CARTONHistorical
57900-002-11579000002116 in 1 PACKAGEHistorical
57900-002-12579000002126 in 1 PACKAGEHistorical