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 42 of 59 · 1,163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up childrens allergy meltsDIPHENHYDRAMINE HCLTarget Corporationf98d1d54-8e11-4bb1-825a-ab5447d378472024-11-07WarningsExact identifier
unii: TC2D6JAD40
RiteAid Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENRITE AID CORPORATION54fc0893-9702-4849-a702-3e84dc9ead032024-10-30WarningsExact identifier
unii: TC2D6JAD40
Rite Aid Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDERITE AID CORPORATION59ba6824-fa6c-4b3f-9f1f-ea194766c8a12024-10-30WarningsExact identifier
unii: TC2D6JAD40
GOOD REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fbe2c0-7749-4c8a-e063-6394a90a7c6e2024-10-30WarningsExact identifier
unii: TC2D6JAD40
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
unii: TC2D6JAD40
Premier Value Nighttime Sleep-Aid Liquid Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Consortium6d24b6e1-7959-47c6-a09b-c7e00a4374952024-10-28WarningsExact identifier
unii: TC2D6JAD40
NytolDIPHENHYDRAMINE HCLMedtech Products Inc.c81d018a-0170-4396-81e9-2e13a53f868a2024-10-25WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.90977b39-8ced-46bf-9d06-15306bce9b352024-10-23WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e221bbce-83de-0f03-e053-2995a90abca52024-10-23WarningsExact identifier
unii: TC2D6JAD40
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.2ab3852d-53a4-411b-a9ad-3ef88ab3ee872024-10-23WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb2024-10-23WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e237550d-711d-5d87-e053-2995a90affce2024-10-23WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter832eb36c-21c6-46d7-b1f8-ab8b6f1e501e2024-10-22WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEBb5a6719e-746b-58ec-e053-2a95a90af0102024-10-21WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst25034563-6422-daf6-e063-6394a90af9802024-10-21WarningsExact identifier
unii: TC2D6JAD40
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER198add5f-20b7-75b0-e063-6394a90a6bd42024-10-21WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGoodSense8972d95a-51da-40b5-8ef1-9dfed220d7eb2024-10-18WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine Oral LiquidDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.d8462e6f-a9fb-4701-97e2-d81a47f3e1962024-10-18WarningsExact identifier
unii: TC2D6JAD40
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART4d93a703-c905-4fb3-b772-11c207065d4d2024-10-17WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIa4d6ecb9-ea67-41ed-917b-9bb4d1e505512024-10-17WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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