FDA.reportPublic FDA data

NDC 21922-045-01 - Mesalamine

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
21922-045
Requested NDC
21922-045-01
Package NDCs from labels
21922-045-01, 21922-045-47, 21922-045-49
Manufacturer
Encube Ethicals, Inc. | Encube Ethicals Private Limited
Effective date
2025-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Encube Ethicals, Inc. | Encube Ethicals Private LimitedEncube Ethicals, Inc. | Encube Ethicals Private Limited2025-10-07HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Bryant Ranch PrepackBryant Ranch Prepack2024-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-045-01Mesalamine60 mL in 1 BOTTLE, DISPENSINGSUSPENSION606
21922-045-47Mesalamine7 in 1 CARTONSUSPENSION76
21922-045-49Mesalamine28 in 1 CARTONSUSPENSION286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-045MESALAMINE SUSPENSION [ENCUBE ETHICALS PRIVATE LIMITED]4Current NDC, 3 package rows20240808_d6b68275-b2a4-4965-9862-cf14acf8c599.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-045-47ML - Milliliter21922-045a3151a33-d466-4e36-a281-5635e7be51f612023-08-08

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 6 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
MesalamineMESALAMINEActavis Pharma, Inc.ba1e3bd4-fbe0-46a5-961e-167ccb09672c2025-03-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
PentasaMESALAMINETakeda Pharmaceuticals America, Inc.e39d9a3d-5d3a-4bb6-aab1-fdbb2a5986062025-01-15Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
D-93POTASSIUM ACETATE, ANTIMONY TRISULFIDE, SAFFRON, UMBILICUS RUPESTRIS, CORALLIUM RUBRUM EXOSKELETON, BOS TAURUS PANCREAS, AND QUERCUS ALBA WOODDNA Labs, Inc.920b6d3d-0c1d-47d3-b148-2a2da97f79e22025-01-13WarningsExact identifier
unii: M911911U02
MesalamineMESALAMINENorthstar Rx LLC.7ac78fa0-60a8-48dd-abc4-a487f98039a22025-01-10Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.4e3b6325-a5bf-4c47-931c-142c0e4d7c3a2025-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAvPAKf2657911-6f06-71fb-e053-2a95a90ae6f72025-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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