FDA.reportPublic FDA data

NDC 0641-0376-21 - 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
0641-0376
Requested NDC
0641-0376-21
Package NDCs from labels
0641-0376-21, 0641-0376-25
Manufacturer
Henry Schein, Inc.
Effective date
2026-10-28
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 onlyHenry Schein, Inc.2026-10-28HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Sportpharm LLCSportpharm LLC2026-07-23HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-05HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2026-03-26HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2026-02-11HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USP Rx onlyREMEDYREPACK INC.2026-01-14HUMAN PRESCRIPTION DRUG LABEL
Deluxe Dental Emergency Kit - Best Dental Kit LLCBest Dental Kit LLC2025-10-16HUMAN PRESCRIPTION DRUG LABEL
Basic Dental Emergency Kit - Best Dental Kit LLCBest Dental Kit LLC2025-10-16HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USP Rx onlyHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
DIPHENHYDRAMINE HYDROCHLORIDE - HF Acquisition Co. LLC, DBA Health FirstHF Acquisition Co. LLC, DBA Health First2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-04-26HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-20HUMAN PRESCRIPTION DRUG LABEL
Sodium Chloride - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Diphenhydramine Hydrochloride - Sina Health IncSina Health Inc2019-02-04HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USP Rx onlyNuCare Pharmaceuticals,Inc.2017-12-15HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Rebel Distributors CorpRebel Distributors Corp2012-03-20HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USP Rx onlyDispensing Solutions, Inc.2011-10-10HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - TYA PharmaceuticalsTYA Pharmaceuticals2011-06-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-0376-21Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION112
0641-0376-25Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0376DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20240410_ec691492-a295-4b48-a1a3-5824931efa97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0376-21ML - Milliliter0641-03768c8139e5-8f02-4c81-87c2-2d319fdbd59412012-07-24
0641-0376-25ML - Milliliter0641-0376a1a960fe-d7c4-417f-91de-2ef619a68ff912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
diphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
benzethonium chlorideINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
benzethonium chlorideINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
waterINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1

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 1 of 865 · 17,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERA SILKYSTAY FOUNDATION 37W1TITANIUM DIOXIDEAmorepacific Corporation5f4105f3-d08b-edb5-e063-6394a90ad28b2026-11-01WarningsExact identifier
unii: 15FIX9V2JP
BiologixCare Sterile Saline Wound WashSODIUM CHLORIDEBIOLOGIX USA, INC.5edb1f1e-122d-f0da-e063-6394a90a4ccd2026-10-29WarningsExact identifier
unii: 451W47IQ8X
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382026-10-27WarningsExact identifier
application number: M012
HERA SILKYSTAY FOUNDATION 28O1TITANIUM DIOXIDEAmorepacific Corporation5ec77f7a-4621-ac0c-e063-6294a90a3f702026-10-26WarningsExact identifier
unii: 15FIX9V2JP
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2026-10-23WarningsExact identifier
application number: M012
rxcui: 1049630
unii: TC2D6JAD40
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack94cb724f-2102-4a6e-82c7-bdbb13303edf2026-10-15WarningsExact identifier
application number: M012
Meijer Adult Mucus Plus chest congestionGUAIFENESINMEIJER DISTRIBUTION, INCf6a23be6-0313-4c23-afb7-576666b80e212026-10-05WarningsExact identifier
application number: M012
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-10-02WarningsExact identifier
unii: 15FIX9V2JP
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Wet Ones Hand Sanitizer Mist Lavender BlossomETHYL ALCOHOLEdgewell Personal Care Brands LLCdae52e15-9161-c8d2-e053-2a95a90adb982026-09-29WarningsExact identifier
unii: 3K9958V90M
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
unii: 362O9ITL9D
SOUR LEMON HAND SANITIZER Pink Guava SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO0adfe188-4613-47dc-a9a3-5c9cfca781a82026-09-17WarningsExact identifier
unii: 3K9958V90M
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.0ca72c89-82c5-4b31-b515-1a8b8e82ec592026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 866511
unii: W5S57Y3A5L
daytime nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationeb58871d-f351-47a1-aeab-254ec6693ddd2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 1737761
unii: V13007Z41A
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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