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 48 of 59 · 1,163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)29b49616-ee5a-4574-81f1-0052addb8f662024-04-22WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b8757d18-6c7d-45de-925a-e2814625f7492024-04-22WarningsExact identifier
unii: TC2D6JAD40
Childrens AllergyDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c573da1e-c7ca-46e6-ad42-4ded2547afc32024-04-22WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)47660794-22cc-4863-a183-e694d27e35432024-04-19WarningsExact identifier
unii: TC2D6JAD40
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB
EZ Nite SleepDIPHENHYRAMINE HYDROCHLORIDEKROGER COMPANY0fec16a4-b4eb-8f8f-e063-6394a90a73272024-04-17WarningsExact identifier
unii: TC2D6JAD40
Dimetapp Cough and AllergyDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare15b0f5ff-202a-d19f-e063-6394a90af2b82024-04-15WarningsExact identifier
unii: TC2D6JAD40
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
unii: TC2D6JAD40
Childrens Dye Free AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC1c4d09ed-4e0f-430d-b17f-6a23f996a55d2024-04-15WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ec691492-a295-4b48-a1a3-5824931efa972024-04-09Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Allergy ChildrensDIPHENHYDRAMINE HYDROCHLORIDEH E Bab28cbc4-7a6f-46e9-8616-be78e8cb24fe2024-04-08WarningsExact identifier
unii: TC2D6JAD40
Robitussin Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC89360fa8-014d-4da8-bb1c-197e3aa522562024-04-06WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma6fe6fe2d-4405-4e7a-a2ed-5eb367d528422024-04-05Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: QTT17582CB
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEGland Pharma Limitedeeb70724-065c-4a73-8e2e-d6b2a625e8d42024-03-22Warnings, Adverse reactionsExact identifier
rxcui: 1723740
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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