FDA.reportPublic FDA data

NDC 0641-6282-01 - Diphenhydramine 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
0641-6282
Requested NDC
0641-6282-01
Package NDCs from labels
0641-6282-01, 0641-6282-25
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenhydramine Hydrochloride Injection, USP Rx onlyREMEDYREPACK INC.2026-09-11HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USP Rx onlyHikma Pharmaceuticals USA Inc.2025-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6282-01Diphenhydramine hydrochloride1 mL in 1 VIALINJECTION13
0641-6282-25Diphenhydramine hydrochloride25 in 1 PACKAGEINJECTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6282DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20250406_829bbcbf-fb27-4484-aff6-a7e7467670af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6282-01ML - Milliliter0641-62828179923d-21c4-4ac9-84ce-45bf645d089b12025-05-14
0641-6282-25ML - Milliliter0641-628286bf09fd-5486-4ec8-a5b7-cd023dec2e8612024-11-05

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 61 of 64 · 1,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCbf7ab250-38b0-ba29-e053-2a95a90a8f322023-04-27Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC95fbf4c2-c96e-2d41-e053-2995a90a0d542023-04-26Warnings, Adverse reactionsExact identifier
rxcui: 1723740
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6671c8d0-1f5d-0d77-e053-2a91aa0a75852023-04-26Warnings, Adverse reactionsExact identifier
application number: ANDA080817
rxcui: 1723740
unii: TC2D6JAD40
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ZylastXP Antiseptic FoamingBENZETHONIUM CHLORIDEInnovative Biodefense86857d95-56ce-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
unii: PH41D05744
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)c62c6319-65eb-37e8-e053-2a95a90a9f902022-12-28WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ba31970a-b952-467c-b3f8-44f7a513de342022-12-28WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.c483bbd6-934b-660a-e053-2995a90a51b32022-12-27WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
unii: TC2D6JAD40
pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.58666a5c-fc92-4c8d-9c04-f0c98dc05c562022-12-20WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7b9ed8ef-ce21-19e7-e053-2a91aa0a81be2022-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1723740
unii: TC2D6JAD40
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC39af6dfa-e822-43a5-bd1a-338cf5da89ce2022-12-09WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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