FDA.reportPublic FDA data

NDC 76420-407 - ketorolac tromethamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76420-407
Package NDCs from labels
76420-407-02
Manufacturer
ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ketorolac tromethamine - ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEMASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM2025-06-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-407-02ketorolac tromethamine2 mL in 1 VIALINJECTION, SOLUTION21

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 106 of 188 · 3,748 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.38863865-9361-fd1a-e063-6394a90a84f42025-06-26WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Squishmallows PattyALCOHOLShenzhen Lantern Scicence Co.,Ltd.38613f78-8480-637d-e063-6394a90a4ef32025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.38626ced-5644-9f82-e063-6294a90ac7a12025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Pistachio BruleALCOHOLShenzhen Lantern Scicence Co.,Ltd.38715507-d881-d8b3-e063-6394a90ad3482025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Juicy BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.3871ec77-de30-0c89-e063-6394a90a9e7a2025-06-25WarningsExact identifier
unii: 3K9958V90M
Meijer Hydrating Power Mist Hand Sanitizer- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.384c26c8-7f2d-8c3a-e063-6394a90aa9082025-06-24WarningsExact identifier
unii: 3K9958V90M
microdot Hand Sanitizing WipeETHYL ALCOHOLCambridge Sensors USA, LLC3284ab00-a17d-d961-e063-6294a90af4ea2025-06-24WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackafc691f8-517a-4d88-8322-87dafec8f0642025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Dehydrated AlcoholALCOHOLXGen Pharmaceuticals DJB, Inc.35a568f3-83cd-452e-e063-6394a90a8c1d2025-06-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Smart Care Barbie Peony Petals Scent HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.531e8a24-3bbb-4cc6-a63f-676e843df3d62025-06-23WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS AND SUEDE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bca6fafa-3d89-419f-89b0-988a331596422025-06-23WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS AND SUEDE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c2c1b567-3fe1-4dd0-b1fd-9c88f1f06a142025-06-20WarningsExact identifier
unii: 3K9958V90M
3810f05e-7fc6-bdab-e063-6294a90abba747ecf0c5-b808-45c2-aa00-ceaae61da3f62025-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 3810f05e-7fc6-bdab-e063-6294a90abba7
spl set id: 47ecf0c5-b808-45c2-aa00-ceaae61da3f6
Ketorolac TromethamineKETOROLAC TROMETHAMINEHenry Schein, Inc.1e65d11b-5aa9-4a6b-b5d6-c19828748fea2025-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204216
rxcui: 860092
unii: 4EVE5946BQ
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.22eaf210-ff25-4bec-a6d4-65c711d2917f2025-06-20WarningsExact identifier
unii: 3K9958V90M
Ketorolac tromethamineKETOROLAC TROMETHAMINEHenry Schein, Inc.606b0f2f-de28-42a9-96f4-cacba2c7c56a2025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204216
rxcui: 1665459
unii: 4EVE5946BQ
Sweet Orange Bergamot and AloeETHYL ALCOHOLALO New York LLC31cecf1e-1d6b-0033-e063-6294a90a7b8e2025-06-18WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Brazilian Caramel ScentedALCOHOLFourstar Group USA, Inc.30aaedbb-ffb9-4d00-a763-d5444074deb22025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Champagne ScentedALCOHOLFourstar Group USA, Inc.52c0f174-3c4d-4e81-91c5-f2c76bffc5302025-06-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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