FDA.reportPublic FDA data

NDC 51662-1248-2 - 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
51662-1248
Requested NDC
51662-1248-2
Package NDCs from labels
51662-1248-1, 51662-1248-2, 51662-1248-3
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
51662-1248-12020-02-07C16284748780-19d75b9d0-bbed-f424-e053-dadaa90a57cePROMETHAZINE HCI INJECTION, USP 50mg/mL 1mL AMPULE
51662-1248-12020-01-31C16284748780-19d75b9d0-bbed-f424-e053-dadaa90a57cePROMETHAZINE HCI INJECTION, USP 50mg/mL 1mL AMPULE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1248-1PROMETHAZINE HCI1 mL in 1 AMPULEINJECTION17
51662-1248-2PROMETHAZINE HCI1 in 1 POUCHINJECTION17
51662-1248-2PROMETHAZINE HCI1 mL in 1 AMPULEINJECTION17
51662-1248-3PROMETHAZINE HCI25 in 1 CASEINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1248PROMETHAZINE HCI INJECTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 4 package rows20240224_744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a.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 4 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: Q40Q9N063P
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAtlantic Biologicals Corp.5022379d-05ef-63f2-e063-6294a90a21892026-04-23Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
unii: 339NCG44TV
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
unii: 339NCG44TV
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: 339NCG44TV
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: 339NCG44TV
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
unii: 339NCG44TV
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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