FDA.reportPublic FDA data

Dicopanol

Manufacturer
California Pharmaceuticals LLC
Effective date
2016-01-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:21:48

Label at a glance#

ProductDicopanol
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure5 sections

Label contents#

Full prescribing information#

Dicopanol, Instructions for Use, Page 2

INSTRUCTIONS FOR USE SECTION

Dicopanol - Instructions 2Dicopanol - Instructions 2

Instructions for Preparation - page 1

INSTRUCTIONS FOR USE SECTION

Dicopanol - Instructions Page 1Dicopanol - Instructions Page 1

Diphenhydramine - label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphen labelDiphen label

Dicopanol. Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dicopanol - Principal display labelDicopanol - Principal display label

Dicopanol - Flavor Suspension label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dicopanol - Flavor Suspension labelDicopanol - Flavor Suspension label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70332-103-012020-01-31C16284748780-19d75b9d0-27a9-f424-e053-dadaa90a57ceDicopanol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70332-103-01Dicopanol1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70332-103DICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [CALIFORNIA PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20160108_271bfbb6-4996-500a-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70332-103-01ML - Milliliter70332-103d153a13f-562a-4c0c-8585-688db565490112016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70332-10370332-103-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
GLYCYRRHIZIN, AMMONIATED3VRD35U26CIACT
PINEAPPLE2A88ZO081OIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
ORANGE5EVU04N5QUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MELATONINJL5DK93RCLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEVIA LEAF6TC6NN0876IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28c7a185-4081-1448-e054-00144ff8d46c271bfbb6-4996-500a-e054-00144ff8d46c2016-01-07Exact identifier
spl id: 28c7a185-4081-1448-e054-00144ff8d46c
spl set id: 271bfbb6-4996-500a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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