FDA.reportPublic FDA data

NDC 54288-142-01 - PAPAVERINE 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
54288-142
Requested NDC
54288-142-01
Package NDCs from labels
54288-142-01, 54288-142-10, 54288-142-25
Manufacturer
BPI Labs LLC
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PAPAVERINE HYDROCHLORIDE - BPI Labs LLCBPI Labs LLC2025-12-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54288-142-102025-02-11PAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-252025-02-11PAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-102025-01-30PAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-252025-01-30PAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-142-01PAPAVERINE HYDROCHLORIDE2 mL in 1 VIALINJECTION, SOLUTION29
54288-142-10PAPAVERINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION109
54288-142-25PAPAVERINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-142PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [BPI LABS LLC]8Current NDC, Legacy NDC, 3 package rows20250213_6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-142-01ML - Milliliter54288-1426eb04eca-f26b-4dc0-a150-e0cb0b08071112021-08-05
54288-142-10ML - Milliliter54288-14220dd0777-f271-4694-b000-d354ca76d6d312021-08-05
54288-142-25ML - Milliliter54288-14249a29eb0-d4c2-4435-8489-83c3d51d9ead12024-06-10

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 20 · 387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
NitrogenNITROGENGas and Supply Carolinas, LLC05a6f3ad-c96a-4345-e063-6294a90a8b7a2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.50df5a35-754d-423f-885c-ade8652596162025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENIndustrial Welding & Tool Supply, Ltd.cee001dd-54ed-4824-aa22-955c791844df2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENIWS Gas and Supply of Texas, LTDbfe95982-1606-4878-95b0-5d3bc662cc2c2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENABSOLUTE AIR LLCe1e64a61-d0e8-0f8e-e053-2a95a90af1862025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSouthern Gas & Supply LLC9f5822ee-0117-4e37-a9c6-555cf5835e9b2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSOUTHERN GAS AND SUPPLY, INC.d6a75eea-7f96-2a42-e053-2995a90a72132025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply9af0511f-2898-d928-e053-2a95a90a75882025-12-08Exact identifier
unii: N762921K75
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
NitrogenNITROGENGas and Supply58dddf10-09e2-4ae6-883d-c5a9ed83d3a72025-12-03Exact identifier
unii: N762921K75
NitrogenNITROGENALLIED GASES AND WELDING SUPPLIES, INC.1a146c9f-1426-10f6-e063-6294a90af2532025-12-02Exact identifier
unii: N762921K75
NitrogenNITROGENMinneapolis Oxygen Companyc3fdbc5c-da70-4cbd-bdee-eddb4d852b262025-12-01Exact identifier
unii: N762921K75
NITROGENNITROGENLampton Welding Supply Company, Inc125eedfb-8ab0-42b3-8393-7e8b9313020b2025-11-26Exact identifier
unii: N762921K75
NITROGENNITROGENVolunteer Welding Supply Incc4c1b8a0-d957-44f8-a7d1-aefe9b251b662025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENSuper Gas, Inc.80a178d8-7173-4e7a-ace9-7fe3fd0e07242025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENGeneral Air Service & Supply Co8e44ea92-d052-438a-b850-ccd147906e472025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENWestair Gases & Equipment, Inc.0268620b-4e8b-4b62-a768-688b477e01712025-11-26Exact identifier
unii: N762921K75
NitrogenNITROGENYoung Welding Supply, Inc86565775-ba7a-4e84-a9d9-72806a871b592025-11-26Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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