FDA.reportPublic FDA data

NDC 72485-101-01 - 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
72485-101
Requested NDC
72485-101-01
Package NDCs from labels
72485-101-01, 72485-101-25, 72485-101-05
Manufacturer
ProPharma Distribution
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenhydramine Hydrochloride - ProPharma DistributionProPharma Distribution2025-12-18HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USPREMEDYREPACK INC.2024-03-15HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride Injection, USPArmas Pharmaceuticals Inc.2023-07-20HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-04-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-101-01Diphenhydramine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
72485-101-05Diphenhydramine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION54
72485-101-25Diphenhydramine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-101DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20230801_c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-101-01ML - Milliliter72485-1018d6392e5-dedb-4e32-9a4a-9b86c9a27dee12019-06-19
72485-101-05ML - Milliliter72485-1015476ad9c-3fc6-46b2-8059-545e2eae843012023-06-06
72485-101-25ML - Milliliter72485-101f341cc59-8aa3-4145-be86-4cfb8b9f196112019-06-19

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 56 of 59 · 1,163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)c62c6319-65eb-37e8-e053-2a95a90a9f902022-12-28WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ba31970a-b952-467c-b3f8-44f7a513de342022-12-28WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.c483bbd6-934b-660a-e053-2995a90a51b32022-12-27WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
unii: TC2D6JAD40
pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.58666a5c-fc92-4c8d-9c04-f0c98dc05c562022-12-20WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7b9ed8ef-ce21-19e7-e053-2a91aa0a81be2022-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1723740
unii: TC2D6JAD40
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC39af6dfa-e822-43a5-bd1a-338cf5da89ce2022-12-09WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC2c7c5349-06c9-401a-88e9-8f91ddb7f91a2022-08-19WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLCa656f8b0-8cb4-4802-b8d3-7b95c0265d562022-02-21WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: QTT17582CB
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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