FDA.reportPublic FDA data

NDC 0781-3422-71 - Phenylephrine Hydrochloride

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
0781-3422
Requested NDC
0781-3422-71
Package NDCs from labels
0781-3422-71, 0781-3422-92, 0781-3422-75, 0781-3422-95, 0781-3422-70
Manufacturer
Sandoz Inc
Effective date
2022-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenylephrine Hydrochloride - Sandoz IncSandoz Inc2022-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3422-70Phenylephrine Hydrochloride1 in 1 CARTONINJECTION120
0781-3422-70Phenylephrine Hydrochloride10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION1020
0781-3422-71Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION120
0781-3422-75Phenylephrine Hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION520
0781-3422-92Phenylephrine Hydrochloride10 in 1 CARTONINJECTION1020
0781-3422-95Phenylephrine Hydrochloride10 in 1 CARTONINJECTION1020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3422PHENYLEPHRINE HYDROCHLORIDE INJECTION [SANDOZ INC]19Current NDC, Legacy NDC, 6 package rows20221018_6feb2da2-05ef-47bb-9d8d-01b81ad69059.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3422-70ML - Milliliter0781-342290051d78-97d7-4932-b6a1-87450da865e412019-10-07
0781-3422-71ML - Milliliter0781-3422687ecc7a-1804-4095-aa56-a52fcf334f6612020-01-03
0781-3422-75ML - Milliliter0781-3422886334d0-4e76-428d-a864-848483a2bc3612019-10-07
0781-3422-92ML - Milliliter0781-34223b9dcb3b-5f4c-4b35-b3b0-f90f06748c6312020-01-03
0781-3422-95ML - Milliliter0781-342212388885-ddd0-47cf-b530-0835df52e29712019-10-07

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 8 of 131 · 2,620 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
unii: 04JA59TNSJ
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
unii: 04JA59TNSJ
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
unii: 04JA59TNSJ
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
unii: 04JA59TNSJ
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDECardinal Health 107, LLC6d59ee85-08e5-452d-a09a-35fcc2a82b752026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 1666372
unii: 04JA59TNSJ
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
unii: 04JA59TNSJ
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
unii: 04JA59TNSJ
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENLinde Inc.11f1ea16-93eb-4994-ba96-d0d7519015e22026-07-16Exact identifier
unii: N762921K75
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
unii: 04JA59TNSJ
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
unii: 04JA59TNSJ
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
unii: 04JA59TNSJ
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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