FDA.reportPublic FDA data

NDC 81033-003-40 - 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
81033-003
Requested NDC
81033-003-40
Package NDCs from labels
81033-003-05, 81033-003-50, 81033-003-52, 81033-003-10, 81033-003-40, 81033-003-41
Manufacturer
Kesin Pharma Corporation
Effective date
2023-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenhydramine Hydrochloride - Kesin Pharma CorporationKesin Pharma Corporation2023-01-16HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81033-003-412024-07-30C16284748780-11e7a6dab-189d-a2ce-e063-dadaa90aadf7Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL
81033-003-522024-07-30C16284748780-11e7a6dab-189d-a2ce-e063-dadaa90aadf7Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-003-05Diphenhydramine Hydrochloride5 mL in 1 CUP, UNIT-DOSELIQUID52
81033-003-10Diphenhydramine Hydrochloride10 mL in 1 CUP, UNIT-DOSELIQUID102
81033-003-40Diphenhydramine Hydrochloride40 in 1 CARTONLIQUID402
81033-003-41Diphenhydramine Hydrochloride8 in 1 CASELIQUID82
81033-003-50Diphenhydramine Hydrochloride50 in 1 CARTONLIQUID502
81033-003-52Diphenhydramine Hydrochloride8 in 1 CASELIQUID82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-003DIPHENHYDRAMINE HYDROCHLORIDE LIQUID [KESIN PHARMA CORPORATION]2Legacy NDC, 6 package rows20230124_c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-003-05ML - Milliliter81033-003f3701be5-9a5c-438f-b934-93806d66ebd412021-10-08
81033-003-10ML - Milliliter81033-0035d902f8f-3bc7-4bea-914d-2933d9172d0912021-10-08
81033-003-40ML - Milliliter81033-0037ba3f437-e501-4726-9cbd-0f7dde86011312021-10-08
81033-003-50ML - Milliliter81033-00329f4b183-8acf-4b5d-9c82-ef796703868412021-10-08

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 30 of 81 · 1,615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLTARGET Corporation97e2c008-1711-dcba-e053-2995a90aa2ff2025-12-16WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLKROGER COMPANYca5418f2-4dc0-ad31-e053-2995a90ac1d32025-12-16WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company8c4b59b8-dfab-4f4a-9966-f07b026a758a2025-12-16WarningsExact identifier
unii: TC2D6JAD40
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company39ce76a3-b7a8-43be-9b61-5c1446cd9e902025-12-12WarningsExact identifier
unii: TC2D6JAD40
Allergy Relief, 24-7 Life by 7-ElevenDIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c4cd6c-327d-5950-e063-6394a90a3a212025-12-12WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
unii: TC2D6JAD40
topcare all night pain relief pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTopco Associates LLCa20f193e-4e64-400a-b605-df08026cb80b2025-12-11WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
unii: TC2D6JAD40
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b22025-12-11WarningsExact identifier
unii: TC2D6JAD40
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
unii: TC2D6JAD40
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd337a0e6-09ed-4db0-8883-ec8a5d56bd352025-12-11WarningsExact identifier
unii: TC2D6JAD40
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb84f37bc-be37-4f2b-83ee-d7d1341844902025-12-11WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
unii: TC2D6JAD40
Topcare ZZZ SleepDIPHENHYDRAMINE HCLTopco Associates LLC27225d04-6deb-436b-89ea-9842c487292e2025-12-11WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
unii: TC2D6JAD40
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Incd956f1b8-91f8-424b-bb6c-704c445b6f4c2025-12-10WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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