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 64 of 64 · 1,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergyDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC73e4f21c-e5ec-42c9-9ec8-1184798570572018-05-14WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC035454a1-d23b-4faf-8fac-a59fc77ce18c2018-05-14WarningsExact identifier
unii: TC2D6JAD40
CVS Health Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.dbd8c221-8409-4851-a6b4-c9f5e8e346e72017-12-30WarningsExact identifier
unii: TC2D6JAD40
ACETAMINOPHEN PMACETAMINOPHEN PMAdvance Pharmaceutical Inc.b172226e-8f2a-4d9c-b7c7-dd737b90463a2017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.e1275cf5-94a7-4a15-be5c-81af95f8dd242017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.c80f9a4c-1055-45d2-8fde-5b57fad3c82a2017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.4e66c626-607f-4558-ab2e-2dd9a25f7be42017-12-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.ab67121e-2477-47dd-a7ec-114453df3fd42017-10-30WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.d1f51b7b-da65-4637-8199-f7d59e6dd1c12017-10-30WarningsExact identifier
unii: TC2D6JAD40
CVS Health Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.03f521f4-d35f-4f66-b3ad-7e58a244eb932017-10-18WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand WipesCHLORHEXIDINE DIGLUCONATE AND BENZETHONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.181e5fa0-ddda-4783-a0b5-ff95bfce6b362017-10-09WarningsExact identifier
unii: PH41D05744
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLC15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c2016-11-22WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLCa083dec1-d4a7-4573-8a14-f5739d5bf1532016-11-22WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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