FDA.reportPublic FDA data

NDC 51662-1247-2 - PROMETHAZINE HCI

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
51662-1247
Requested NDC
51662-1247-2
Package NDCs from labels
51662-1247-1, 51662-1247-2, 51662-1247-3
Manufacturer
HF Acquisition Co. LLC, DBA HealthFirst
Effective date
2024-02-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HCI - HF Acquisition Co. LLC, DBA HealthFirstHF Acquisition Co. LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1247-12020-02-07C16284748780-19d75b9d1-13d4-f424-e053-dadaa90a57cePROMETHAZINE HCI INJECTION, USP 25mg/mL 1mL VIAL
51662-1247-12020-01-31C16284748780-19d75b9d1-13d4-f424-e053-dadaa90a57cePROMETHAZINE HCI INJECTION, USP 25mg/mL 1mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1247-1PROMETHAZINE HCI1 mL in 1 VIAL, SINGLE-DOSEINJECTION17
51662-1247-2PROMETHAZINE HCI1 mL in 1 POUCHINJECTION17
51662-1247-3PROMETHAZINE HCI25 in 1 CASEINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1247PROMETHAZINE HCI INJECTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 3 package rows20240224_7447e8c6-c198-cd2d-e053-2a91aa0a3895.zip

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 28 · 552 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Bio Biological DetoxECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PROPOLIS, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYMUS SERPYLLUM, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYROIDINUM (SUIS), BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, PYROGENIUM, ANTHRACINUM, ARSENICUM, CARBOLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, LACHESIS, VARIOLINUM, BOTULINUM, DYSENTERY BACILLUS, GAERTNER BACILLUS, FRANCISELLA TULARENSIS, COXIELLA BURNETII, LAC CANINUM, MALARIA OFFICINALIS,BioActive Nutritional, Inc.9a6671bb-b070-4f97-bdc0-189cf60407ee2025-12-30WarningsExact identifier
unii: 339NCG44TV
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Absorbine Jr. Pro RollonABSORBINE JR. PRO ROLLONClarion Brands, LLC470efcd0-d350-3dc4-e063-6394a90ab8c12025-12-28WarningsExact identifier
unii: 339NCG44TV
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
unii: 339NCG44TV
calcium chlorideCALCIUM CHLORIDEAmneal Pharmaceuticals LLC7649c84f-f1c2-4169-962d-ccbac56523a92025-12-22Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
unii: R61ZEH7I1I
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: Q40Q9N063P
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECosette Pharmaceuticals, Inc.3b02cda4-9b24-79c9-e063-6294a90af5b92025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Epl-Cell RepairCELL REPAIR AIDVitality Works, Inc.134d1cc1-2300-409d-b562-98ce807e77b32025-12-17WarningsExact identifier
unii: M4I0D6VV5M
HivesECHINACEA ANG, APIS MEL, ARSENICUM ALB, CARBOLICUM AC, LEDUM, RHUS TOX, SULPHUR, URTICA URENSNatural Creations, Incc453ac40-1865-4297-b7d4-c8e637bb5f942025-12-16WarningsExact identifier
unii: 339NCG44TV
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
unii: 339NCG44TV
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECranbury Pharmaceuticals, LLC785c605e-1907-4fac-8b69-d504a2076f8e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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