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 49 of 81 · 1,603 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
unii: TC2D6JAD40
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLHarris Teeter, LLC322a71bb-fc68-4a03-8a24-20cbdbe6d91b2025-03-13WarningsExact identifier
unii: TC2D6JAD40
REVASOL SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
unii: TC2D6JAD40
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.1a7189ba-2d52-44fc-83a4-b9f6156c62ff2025-03-07WarningsExact identifier
unii: TC2D6JAD40
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
unii: TC2D6JAD40
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
unii: TC2D6JAD40
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCfc574e74-1fdc-4a61-a1ed-492ae43faed22025-02-21Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
unii: TC2D6JAD40
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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