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 26 of 59 · 1,163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
unii: TC2D6JAD40
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy and HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdc249163-26dd-42ca-b423-2f16299f2d652025-11-07WarningsExact identifier
unii: TC2D6JAD40
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores Inc1a1f41c4-5430-4cff-873e-6547dadc87792025-11-06WarningsExact identifier
unii: TC2D6JAD40
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Target Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation76299495-7259-4bbe-8393-7eabfe22715a2025-11-05WarningsExact identifier
unii: TC2D6JAD40
up and up naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTarget Corporationc0769941-bcf2-4237-b70c-a79089ad53352025-11-05WarningsExact identifier
unii: TC2D6JAD40
dg health naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMDolgencorp Inc6c2c087c-e36d-4971-b977-d3cab6d6edee2025-11-05WarningsExact identifier
unii: TC2D6JAD40
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
unii: TC2D6JAD40
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
unii: TC2D6JAD40
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Free and Pure Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREEN COMPANY93182db8-05bc-4eb5-aa14-cef58de253592025-10-31WarningsExact identifier
unii: TC2D6JAD40
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDECompany name: Topco Associates, LLC7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec2025-10-31WarningsExact identifier
unii: TC2D6JAD40
Dye Free Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLC6ddf6b16-0ff3-4014-9f73-33e854397fe52025-10-31WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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