FDA.reportPublic FDA data

Tabradol

Manufacturer
California Pharmaceuticals, LLC
Effective date
2016-01-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:21:47

Label at a glance#

ProductTabradol
Active ingredientCYCLOBENZAPRINE HYDROCHLORIDE
Label structure5 sections

Label contents#

Full prescribing information#

Tabradol - Pharmacist Instructions page 2

INSTRUCTIONS FOR USE SECTION

Tabradol pharmacist instructions page 2Tabradol pharmacist instructions page 2

Tabradol - Label

INACTIVE INGREDIENT SECTION

Tabradol Cyclobenzaprine labelTabradol Cyclobenzaprine label

Tabradol - Inactive ingredient - flavor label

INACTIVE INGREDIENT SECTION

Tabradol flavor labelTabradol flavor label

Tabradol - Pharmacist instructions Page 1

INSTRUCTIONS FOR USE SECTION

Tabradol - pharmacist instructions page 1Tabradol - pharmacist instructions page 1

Tabradol - Principal Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tabradol Principal labelTabradol Principal label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYCLOBENZAPRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12870332-106-01Tabradol Principal Display CS125-A1 - Label Tabradol Kit - California Pharma LLC.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70332-106-012020-01-31C16284748780-19d75b9cf-fb42-f424-e053-dadaa90a57ceTabradol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70332-106-01Tabradol1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70332-106TABRADOL (CYCLOBENZAPRINE HYDROCHLORIDE) KIT [CALIFORNIA PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20160101_273003a5-23a9-21e4-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70332-106-01ML - Milliliter70332-1061ea1b8f8-21a4-4e11-8833-7ea55454278c12016-09-02

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
70332-10670332-106-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CYCLOBENZAPRINE HYDROCHLORIDE0VE05JYS2PACTIB
GLYCERINPDC6A3C0OXIACT
CHERRYBUC5I9595WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT

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
273003a5-23aa-21e4-e054-00144ff88e88273003a5-23a9-21e4-e054-00144ff88e882016-01-01Exact identifier
spl id: 273003a5-23aa-21e4-e054-00144ff88e88
spl set id: 273003a5-23a9-21e4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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