FDA.reportPublic FDA data

NDC 70069-371-01 - Prochlorperazine Edisylate

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
70069-371
Requested NDC
70069-371-01
Package NDCs from labels
70069-371-01, 70069-371-25
Manufacturer
Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited
Effective date
2025-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prochlorperazine Edisylate Injection, USP 5 mg/ mL Rx onlySomerset Therapeutics, LLC | Somerset Therapeutics Private Limited2025-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-371-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION25
70069-371-25Prochlorperazine Edisylate25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-371PROCHLORPERAZINE EDISYLATE INJECTION [SOMERSET THERAPEUTICS, LLC]5Current NDC, 2 package rows20241018_d382e3d4-3175-42f2-b9eb-d9a7b97cbbfc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-371-01ML - Milliliter70069-3716b7ec296-2374-4306-9814-3c034e715c3112024-11-05
70069-371-25ML - Milliliter70069-371d88b8e4e-caab-4973-9cab-2673fadd9f8312024-11-05

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 7 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEGland Pharma Limiteda0fd3d58-7470-4d0f-9e6c-84e92c02a97f2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
unii: 3980JIH2SW
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAvenacy Inc.fd07a1a3-c0df-4926-9964-07348e45a5fd2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0338b221-db43-45c9-a829-d970fe6643ab2024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECosette Pharmaceuticals, Inc.4687b9f5-2d67-4fe0-af4d-2415a42b52922024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
unii: 3980JIH2SW
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
unii: 3980JIH2SW
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
unii: 3980JIH2SW
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAmneal Pharmaceuticals LLCe913d678-7a5d-4e74-9e9c-1b9a3affd2652024-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEEugia US LLC24358d03-d06d-4946-8ebd-a62bc15d33c02024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS

Reported adverse events (FAERS/openFDA)#

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