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 27 of 64 · 1,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Nighttime SleepAidDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANY3802d57e-7943-c0c2-e063-6394a90a75802025-11-20WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
unii: TC2D6JAD40
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
unii: TC2D6JAD40
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepacke1d545dc-9222-4d61-964d-1c781215d7d22025-11-18WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.6178d3a1-0741-49a4-be81-c4f7d29f8b2a2025-11-18Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Benadryl AllergyDIPHENHYDRAMINE HYDROCHLORIDER J General Corporationc46c01c0-29f4-400c-bef5-14b3eb944c512025-11-17WarningsExact identifier
unii: TC2D6JAD40
TYLENOL PM EXTRA STRENGTHACETAMINOPHENR J General Corporationa40ea0e3-d666-4605-b5e0-beeaf8f586f22025-11-17WarningsExact identifier
unii: TC2D6JAD40
Sleep-Aid NighttimeDIPHENHYDRAMINE HCLCVS PHARMACY6bd1ad2e-8f47-412d-8620-b149ad90c2922025-11-17WarningsExact identifier
unii: TC2D6JAD40
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltda7433f39-a8d9-4c78-864d-d7ef193a7daf2025-11-16WarningsExact identifier
unii: PH41D05744
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ec902e52-0f48-4a61-b67d-17e1c14616192025-11-15WarningsExact identifier
unii: TC2D6JAD40
Nighttime Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporationf8d50b4e-735d-4d91-a18d-be3537e46e992025-11-15WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf1157dbc-d86c-4554-954c-60a74674ff6b2025-11-15WarningsExact identifier
unii: TC2D6JAD40
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
unii: TC2D6JAD40
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCLDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.c1873a4c-661f-4896-bcc0-f6d3a655de942025-11-13WarningsExact identifier
unii: TC2D6JAD40
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
unii: TC2D6JAD40
equaline allergyDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI8e4eb1eb-5b55-4531-94d2-998425ec80ed2025-11-13WarningsExact identifier
unii: TC2D6JAD40
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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