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 19 of 64 · 1,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
unii: TC2D6JAD40
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
unii: TC2D6JAD40
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
unii: TC2D6JAD40
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsExact identifier
unii: TC2D6JAD40
Unisom SleepMinis Nighttime Sleep-AidDIPHENHYDRAMINE HCLChattem, Inc.a9a44c2f-65eb-4a5a-9e72-43652dce57f72026-01-14WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEREMEDYREPACK INC.62edde3d-b41b-40fc-ac18-b749035de8312026-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA080817
unii: TC2D6JAD40
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
unii: TC2D6JAD40
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
HISTAPRINDIPHENHYDRAMINENorMed38786a65-a12b-4479-b63c-b7c15410da042026-01-14WarningsExact identifier
unii: TC2D6JAD40
Blood ClottingBENZETHONIUM CHLORIDE AND LIDOCAINEHART Health21668731-8b8a-404f-80ab-962a0a9d5f632026-01-14WarningsExact identifier
unii: PH41D05744
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
unii: TC2D6JAD40
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
unii: TC2D6JAD40
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsExact identifier
unii: TC2D6JAD40
BandageBENZOCAINE AND BENZETHONIUM CHLORIDEHART Health6de57472-6dd0-43b6-8a82-fe459fa99ddb2026-01-14WarningsExact identifier
unii: PH41D05744
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
unii: TC2D6JAD40
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
unii: PH41D05744
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC462ca6cd-8eec-09df-e063-6294a90ac8802026-01-13WarningsExact identifier
unii: TC2D6JAD40
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
unii: PH41D05744
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
unii: PH41D05744
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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