FDA.reportPublic FDA data

Dexlido Kit

Product NDC
76420-767
Requested package NDC
76420-767-01
11-digit product format
764200767
Labeler code
76420
Product ID
76420-767_47db0652-74e7-2922-e063-6394a90a027c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Povidine Iodine
Dosage form
KIT
Route
INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-07-25
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dexlido Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
797730Internal RxNorm lookup
1737568Internal RxNorm lookup
1812079Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
65428186-5fbb-4e1a-ae60-8824f3d62179Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-767-01Dexlido Kit1 in 1 CARTONKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-767-01EA - Each76420-767fe431760-f589-43cd-b604-6ab3271f53bb12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
BupivacaineACTIVE MOIETYY8335394RODEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
IodineACTIVE MOIETY9679TC07X4DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
LidocaineACTIVE MOIETY98PI200987DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
LidocaineACTIVE MOIETY98PI200987DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-767DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]9Current NDC, Legacy NDC, 1 package rows20241008_65428186-5fbb-4e1a-ae60-8824f3d62179.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexlido KitDEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.65428186-5fbb-4e1a-ae60-8824f3d621792026-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 76420-767-01
ndc (product): 76420-767
ndc11 (package): 76420076701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSN65428186-5fbb-4e1a-ae60-8824f3d6217910
797544isopropyl alcohol 70 % Medicated PadPSN65428186-5fbb-4e1a-ae60-8824f3d6217910
1737568lidocaine HCl 1 % in 2 ML InjectionPSN65428186-5fbb-4e1a-ae60-8824f3d6217910
797730povidone-iodine 10 % Medicated PadPSN65428186-5fbb-4e1a-ae60-8824f3d6217910
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCD65428186-5fbb-4e1a-ae60-8824f3d6217910
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD65428186-5fbb-4e1a-ae60-8824f3d6217910
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD65428186-5fbb-4e1a-ae60-8824f3d6217910
797730povidone-iodine 100 MG/ML Medicated PadSCD65428186-5fbb-4e1a-ae60-8824f3d6217910
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797544isopropyl alcohol 70 % Medicated PadSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797544isopropyl alcohol 70 % Topical ClothSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797544isopropyl alcohol 70 % Topical SwabSY65428186-5fbb-4e1a-ae60-8824f3d6217910
1737568lidocaine HCl 1 % per 2 ML InjectionSY65428186-5fbb-4e1a-ae60-8824f3d6217910
1737568lidocaine HCl 20 MG per 2 ML InjectionSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797730povidone-iodine 10 % Medicated PadSY65428186-5fbb-4e1a-ae60-8824f3d6217910
797730povidone-iodine 10 % Medicated SwabstickSY65428186-5fbb-4e1a-ae60-8824f3d6217910
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Medicated PadPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 1 % in 2 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1725079Marcaine 0.25 % in 10 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated PadPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBDfd895819-b7d4-43bd-b804-f7b0722a00e91
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 100 MG/ML Medicated PadSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
172507910 ML Marcaine 2.5 MG/ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Topical ClothSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Topical SwabSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 1 % per 2 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 20 MG per 2 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1725079Marcaine 0.25 % in 10 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated SwabstickSYfd895819-b7d4-43bd-b804-f7b0722a00e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-767-01764200767011 KIT in 1 CARTON (76420-767-01) * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL1 kit2016-05-230000-00-00NoNoCurrent