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 45 of 64 · 1,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.76724432-ff3c-404f-ba1f-5af68e3ab8c42024-12-02WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
unii: TC2D6JAD40
NOTTS - Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLCe6754f62-e3b2-773f-e053-2a95a90ad36a2024-12-02WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf4468840-e17c-6888-e053-2995a90a04a02024-12-02WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Inc.6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f2024-12-02WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HClDIPHENHYDRAMINE HCLCVS Pharmacy, Inc.6dd802ec-fc26-3913-e053-2a91aa0ad05d2024-12-02WarningsExact identifier
unii: TC2D6JAD40
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
unii: TC2D6JAD40
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
unii: TC2D6JAD40
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
unii: TC2D6JAD40
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
unii: TC2D6JAD40
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
unii: TC2D6JAD40
MicroKlenz AntimicrobialBENZETHONIUM CHLORIDEMedline Industries, LP115dda08-709c-490a-9693-419b514419602024-11-26WarningsExact identifier
unii: PH41D05744
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC236ff457-0ec1-9c49-e063-6394a90a707a2024-11-26WarningsExact identifier
unii: TC2D6JAD40
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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