FDA.reportPublic FDA data

NDC 70518-2896-1 - Promethazine 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
70518-2896
Requested NDC
70518-2896-1
Package NDCs from labels
70518-2896-1, 70518-2896-0
Manufacturer
REMEDYREPACK INC.
Effective date
2022-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride Injection, USPREMEDYREPACK INC.2022-02-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2896-02022-02-08C16284748780-1d6a99b39-6253-a426-e053-dadaa90af4c2Promethazine Hydrochloride Injection, USP
70518-2896-02022-01-28C16284748780-1d6a99b39-6253-a426-e053-dadaa90af4c2Promethazine Hydrochloride Injection, USP

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 1 of 27 · 530 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
unii: 339NCG44TV
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
unii: 339NCG44TV
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDERedpharm Drug5a797d11-19b0-fd33-e063-6394a90a4d582026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Calcium ChlorideCALCIUM CHLORIDEREMEDYREPACK INC.801f110c-7800-4689-a37a-f31d99c0f9302026-08-28Adverse reactionsExact identifier
unii: M4I0D6VV5M
Calcium ChlorideCALCIUM CHLORIDE INJECTIONREMEDYREPACK INC.3089499b-142d-482e-889d-1db4da7b11522026-08-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.974208c8-4aad-4fb9-991b-cf30850342722026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC5991de26-891a-153a-e063-6294a90a46332026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5590f356-0904-58f6-e063-6294a90a6ad52026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
unii: 339NCG44TV
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
unii: 339NCG44TV
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
unii: 339NCG44TV
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: 339NCG44TV
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: Q40Q9N063P
Medi-ChordHOMEOPATHIC LIQUIDEnergetix Corporation57bc618b-15bd-4d04-8037-fb192e743e302026-08-11WarningsExact identifier
unii: Q40Q9N063P
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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