FDA.reportPublic FDA data

NDC 63323-664-41 - 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
63323-664
Requested NDC
63323-664-41
Package NDCs from labels
63323-664-00, 63323-664-01, 63323-664-41, 63323-664-16
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIPHENHYDRAMINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2026-08-19HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-15HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-02-21HUMAN PRESCRIPTION DRUG LABEL
DiphenhydrAMINE Hydrochloride Injection, USPREMEDYREPACK INC.2024-11-22HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-14HUMAN PRESCRIPTION DRUG LABEL
DIPHENHYDRAMINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-10HUMAN PRESCRIPTION DRUG LABEL
Diphenhydramine Hydrochloride - General Injectables and Vaccines, IncGeneral Injectables and Vaccines, Inc2019-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-664-00Diphenhydramine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-664-01Diphenhydramine25 in 1 TRAYINJECTION, SOLUTION256
63323-664-16Diphenhydramine25 in 1 TRAYINJECTION, SOLUTION254
63323-664-41Diphenhydramine1 mL in 1 VIALINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-664DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250302_fc574e74-1fdc-4a61-a1ed-492ae43faed2.zip
63323-664DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241019_921b9f64-1096-46db-866a-67f0f9ff6790.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-664-00ML - Milliliter63323-6645b65cd96-e4fc-4893-9bfc-598e2314bfde12020-08-06
63323-664-01ML - Milliliter63323-664dd6634b3-49ca-48c5-82b7-6296c47336eb12012-07-24
63323-664-16ML - Milliliter63323-66451a026f0-e2e5-45c4-9a3a-7e8c5c7853c512016-02-04
63323-664-41ML - Milliliter63323-664681f1020-2f3c-4f9e-a526-ae737a575f0c12020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
diphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

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 2 of 58 · 1,149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
unii: TC2D6JAD40
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
unii: TC2D6JAD40
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9713d8ee-6ab2-2fdf-e053-2a95a90a9e192026-08-19Warnings, Adverse reactionsExact identifier
application number: ANDA040466
ndc (package): 51662-1374-3
ndc (package): 51662-1374-2
ndc (package): 51662-1374-1
ndc (product): 51662-1374
rxcui: 1723740
spl id: 596c6e45-0e6d-3332-e063-6294a90a9562
spl set id: 9713d8ee-6ab2-2fdf-e053-2a95a90a9e19
unii: TC2D6JAD40
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
unii: TC2D6JAD40
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
unii: TC2D6JAD40
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
unii: TC2D6JAD40
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
unii: TC2D6JAD40
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
unii: TC2D6JAD40
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
unii: TC2D6JAD40
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
unii: TC2D6JAD40
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact identifier
unii: TC2D6JAD40
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
unii: TC2D6JAD40
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
unii: TC2D6JAD40
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
unii: TC2D6JAD40
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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