FDA.reportPublic FDA data

NDC 76045-235-01 - 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
76045-235
Requested NDC
76045-235-01
Package NDCs from labels
76045-235-01, 76045-235-10
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi, USA LLC
Effective date
2025-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SODIUM HYDROXIDE - Fresenius Kabi USA, LLC | Fresenius Kabi, USA LLCFresenius Kabi USA, LLC | Fresenius Kabi, USA LLC2025-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-235-01Diphenhydramine Hydrochloride1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION113
76045-235-01Diphenhydramine Hydrochloride1 in 1 BLISTER PACKINJECTION, SOLUTION113
76045-235-10Diphenhydramine Hydrochloride24 in 1 CARTONINJECTION, SOLUTION2413

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7

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 9 of 59 · 1,162 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Nighttime Sore Throat Hot ReliefACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEPrestige Brands Holdings, Inc.9c13c052-a5d1-43d2-8d29-4ea011a971ac2026-05-20WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)7af82ca5-ea36-4b72-88b8-0fe68348d2692026-05-19WarningsExact identifier
unii: TC2D6JAD40
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
unii: TC2D6JAD40
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.38df2308-f6f9-4476-ad34-4b5bc5f9fdf22026-05-18WarningsExact identifier
unii: TC2D6JAD40
Allergy Plus Headache ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.88e3b969-79d0-4e64-95c0-c5cfd41e365f2026-05-18WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.db264d2f-bf81-4da2-8595-2bfa1e4ba2f12026-05-18WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC50df93bf-fe72-48f6-a02e-ea9a313d47c22026-05-15Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
unii: TC2D6JAD40
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC51bb483f-3fe6-8a94-e063-6394a90acf7d2026-05-13Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreen Companyec3618dd-8713-4f3c-b639-fc240021c7be2026-05-13WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLRite Aid Corporationfbedb50d-b96f-4ce4-a1dc-d2b357cf6de12026-05-13WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
unii: TC2D6JAD40
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
unii: TC2D6JAD40
good sense naproxen sodiumDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUML. Perrigo Companyf548aa3d-b35e-458a-9815-3595a451ab782026-05-11WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacy0be4ef9a-2484-41dd-8bb8-e92d411f13842026-05-11WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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