FDA.reportPublic FDA data

NDC 81033-003-05 - 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
81033-003-05
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 8 of 81 · 1,615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
unii: TC2D6JAD40
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
unii: TC2D6JAD40
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
unii: TC2D6JAD40
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
unii: TC2D6JAD40
Allergy ChildrensDIPHENHYDRAMINE HCLDOLGENCORP, LLC218c447e-9ddd-428a-9b33-0acec35e0d1b2026-06-17WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.a9d5f9f4-ddec-4ad6-ad06-4a612008bb682026-06-17WarningsExact identifier
unii: TC2D6JAD40
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Companye49d2a0f-6588-439b-8a46-c073e0bc4f9a2026-06-17WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
unii: TC2D6JAD40
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
unii: TC2D6JAD40
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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